Medical instruments for performing minimally-invasive procedures

ABSTRACT

Apparatus for performing a minimally-invasive procedure, the apparatus comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly comprising a knife; a handle attached to the proximal end of the shaft; wherein the shaft comprises a flexible portion and an articulating portion, wherein the flexible portion extends distally from the handle and the articulating portion extends distally from the flexible portion; wherein at least one articulation cable extends from the handle to the articulating portion, such that when tension is applied to the at least one articulation cable, the articulating portion deflects; wherein an actuation element extends through the shaft from the handle to the knife, such that when the actuation element is moved, the knife is moved; and wherein the actuation element transmits electrical power from the handle to the knife.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application:

(1) is a continuation-in-part of pending prior U.S. patent applicationSer. No. 15/298,605, filed Oct. 20, 2016 by Lumendi Ltd. and JonathanO'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY-INVASIVEPROCEDURES (Attorney's Docket No. LUMENDI-051114), which patentapplication claims benefit of (i) prior U.S. Provisional PatentApplication Ser. No. 62/244,026, filed Oct. 20, 2015 by Lumendi Ltd. andJonathan O'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMINGMINIMALLY-INVASIVE PROCEDURES (Attorney's Docket No. LUMENDI-5 PROV);and (ii) prior U.S. Provisional Patent Application Ser. No. 62/400,759,filed Sep. 28, 2016 by Lumendi Ltd. and Jonathan O'Keefe et al. forMEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY-INVASIVE PROCEDURES(Attorney's Docket No. LUMENDI-1114 PROV); and

(2) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/855,308, filed May 31, 2019 by Lumendi Ltd. and JonathanO'Keefe et al. for MEDICAL INSTRUMENTS FOR PERFORMING MINIMALLY-INVASIVEPROCEDURES (Attorney's Docket No. LUMENDI-18 PROV).

The four (4) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to medical instruments in general, and moreparticularly to medical instruments for performing minimally-invasiveprocedures.

BACKGROUND OF THE INVENTION

Minimally-invasive medical procedures have become commonplace. In atypical minimally-invasive procedure, access to an internal site iseffected through one or more small portals (e.g., a natural bodyorifice, a small incision in the skin, etc.). A scope (e.g., acolonoscope, an arthroscope, an endoscope, etc.) is inserted through aportal so as to provide visualization of the internal site, and then oneor more medical instruments are inserted, either through the same portal(e.g., via an internal channel in the scope) or through another portal,so that the medical instruments can be used to carry out a procedure atthe internal site under the visualization provided by the scope.

In many cases the internal site may be difficult to reach due toanatomical constraints, equipment limitations, etc. By way of examplebut not limitation, in many situations it may be desirable for a medicalinstrument to be advanced to the internal site through an internalchannel of a scope, or for a medical instrument to be advanced to theinternal site alongside the scope, and then bent (e.g., along a shortradius) so as to enter the visual field of the scope, so that thedesired procedure is carried out under the visualization provided by thescope. And in many cases, the path along which the medical instrumentneeds to be advanced may be tortuous (e.g., endoluminally within thecolon). In this situation, it is necessary for the medical instrument tobe highly flexible, capable of articulating with a range of differentmotions, and configured for precise control, while being operated (e.g.,along a tortuous path) from only the handle end (i.e., the proximal end)of the medical instrument. In practice, this is extremely difficult toachieve.

The present invention is intended to provide a novel medical instrumentcapable of such function.

SUMMARY OF THE INVENTION

The present invention comprises a novel medical instrument forperforming minimally-invasive procedures. The novel medical instrumentis highly flexible, capable of articulating with a range of differentmotions, and configured for precise control, while being operated (e.g.,along a tortuous path) from only the handle end of the medicalinstrument.

The novel medical instrument generally comprises a handle and a shaftextending distally from the handle. The shaft generally comprises anelongated, flexible proximal portion and a distal articulating portionwhich is mounted to the distal end of the flexible proximal portion. Anend effector is mounted to the distal end of the distal articulatingportion. The end effector may take many different forms (e.g., graspers,injection needles, scissors, hot snares, monopolar probes, hemostasisclips, bipolar forceps, suction tubes, single-fire or multi-fire closuredevices such as staplers and tackers, dissector forceps, retrievalbaskets, monopolar scissors, monopolar knife, monopolar knife withflushing capabilities, etc.). For clarity of illustration, the endeffector is shown in the figures as a grasper. The handle may take anyone of many different forms (e.g., a pistol grip, a shaft grip, etc.).For clarity of illustration, the handle is shown in the figures as apistol grip.

In accordance with the present invention, the flexible proximal portionof the shaft is configured to be a highly flexible element capable ofextending a significant length (e.g., 95 cm-140 cm) along a tortuouspath, the distal articulating portion of the shaft is configured to becapable of universal articulation relative to the distal end of theflexible proximal portion of the shaft, and the end effector isconfigured to be selectively rotated relative to the distal end of thedistal articulating portion and may be selectively actuated, with allfunctions able to be carried out by a single hand of a user via thehandle. In one preferred form of the invention, substantially the entireshaft of the medical instrument is flexible, with the portion of theshaft proximal to a transition point (i.e., the flexible proximalportion) being passively flexible (e.g., able to follow a tortuouspath), and the portion of the shaft distal to the transition point(i.e., the distal articulating portion) being actively flexible (e.g.,able to be universally articulated to a desired configuration).

As will hereinafter be described in further detail, the novel medicalinstrument is capable of at least the following motions:

Motion 1—longitudinal movement of the end effector by longitudinalmovement of the handle (sometimes hereinafter referred to as a“longitudinal motion function”);

Motion 2—rotational movement of the end effector by rotational movementof the handle (sometimes hereinafter referred to as a “torqueing motionfunction”);

Motion 3—articulating movement of the end effector relative to thehandle by articulating the distal articulating portion of the shaftrelative to the distal end of the flexible proximal portion of the shaft(sometimes hereinafter referred to as a “universal articulationfunction”);

Motion 4—rotational movement of the end effector relative to the distalend of the distal articulating portion of the shaft by rotating the endeffector relative to the shaft (sometimes hereinafter referred to as a“roticulation function”); and

Motion 5—actuation of the end effector, e.g., selectively movingelements of the end effector relative to one another so as to carry outa medical procedure, e.g., opening and closing the jaws of agrasper-type end effector (sometimes hereinafter referred to as a “jawopen/close function”).

In one preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft;    -   wherein the shaft comprises a flexible portion extending        distally from the proximal end of the shaft, and an articulating        portion extending proximally from the distal end of the shaft,        and wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, each of the        plurality of articulation cables having an articulation cable        housing disposed about the articulation cable such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends, with the        articulation cable housings providing a counterforce to the        flexible spine;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates; and    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, each of the            plurality of articulation cables having an articulation            cable housing disposed about the articulation cable such            that when tension is applied to at least one of the            plurality of articulation cables, the flexible spine bends,            with the articulation cable housings providing a            counterforce to the flexible spine;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates; and        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated; and

using the apparatus to perform a minimally-invasive procedure.

In another preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft;    -   wherein the shaft comprises a flexible portion extending        distally from the proximal end of the shaft, and an articulating        portion extending proximally from the distal end of the shaft,        and wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates, wherein the rotatable        element comprises a hollow tubular structure extending distally        from the handle, the hollow tubular structure being formed out        of a plurality of filars which are wound and swaged together,        and further wherein the rotatable element further comprises a        laser-cut hypotube secured to the hollow tubular structure, such        that when the hollow tubular structure is rotated, the laser-cut        hypotube is also rotated; and    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, such that            when tension is applied to at least one of the plurality of            articulation cables, the flexible spine bends;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates, wherein the            rotatable element comprises a hollow tubular structure            extending distally from the handle, the hollow tubular            structure being formed out of a plurality of filars which            are wound and swaged together, and further wherein the            rotatable element further comprises a laser-cut hypotube            secured to the hollow tubular structure, such that when the            hollow tubular structure is rotated, the laser-cut hypotube            is also rotated; and        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated; and

using the apparatus to perform a minimally-invasive procedure.

In another preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft;    -   wherein the shaft comprises a flexible portion extending        distally from the proximal end of the shaft, and an articulating        portion extending proximally from the distal end of the shaft,        and wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates;    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated; and    -   wherein the flexible portion of the shaft comprises an outer        coil secured to the flexible spine, a rigid tube configured to        rotate relative to the handle, and an outer covering secured to        the rigid tube and the flexible spine, such that rotation of the        rigid tube causes rotation of the outer covering which causes        rotation of the flexible spine.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, such that            when tension is applied to at least one of the plurality of            articulation cables, the flexible spine bends;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates;        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated; and        -   wherein the flexible portion of the shaft comprises an outer            coil secured to the flexible spine, a rigid tube configured            to rotate relative to the handle, and an outer covering            secured to the rigid tube and the flexible spine, such that            rotation of the rigid tube causes rotation of the outer            covering which causes rotation of the flexible spine; and

using the apparatus to perform a minimally-invasive procedure.

In another preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft;    -   wherein the shaft comprises a flexible portion extending        distally from the proximal end of the shaft, and an articulating        portion extending proximally from the distal end of the shaft,        and wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates;    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated; and    -   wherein the proximal end of the shaft further comprises a rigid        portion, and wherein the apparatus further comprises a tool        support mounted to a patient support, the tool support        comprising an opening for receiving the rigid portion.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, such that            when tension is applied to at least one of the plurality of            articulation cables, the flexible spine bends;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates;        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated; and        -   wherein the proximal end of the shaft further comprises a            rigid portion, and wherein the apparatus further comprises a            tool support mounted to a patient support, the tool support            comprising an opening for receiving the rigid portion; and

using the apparatus to perform a minimally-invasive procedure.

In another preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft;    -   wherein the shaft comprises a flexible portion extending        distally from the proximal end of the shaft, and an articulating        portion extending proximally from the distal end of the shaft,        and wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates; and    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated;    -   the shaft being configured such that when the articulating        portion has been articulated, rotation of the rotatable element        occurs without the build-up of spring energy within the shaft.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, such that            when tension is applied to at least one of the plurality of            articulation cables, the flexible spine bends;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates; and        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated;        -   the shaft being configured such that when the articulating            portion has been articulated, rotation of the rotatable            element occurs without the build-up of spring energy within            the shaft; and

using the apparatus to perform a minimally-invasive procedure.

In another preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a tool comprising:

-   -   a shaft having a distal end and a proximal end;    -   a handle attached to the proximal end of the shaft; and    -   an end effector attached to the distal end of the shaft; wherein        the shaft comprises a flexible portion extending distally from        the proximal end of the shaft, and an articulating portion        extending proximally from the distal end of the shaft, and        wherein the articulating portion comprises a flexible spine;    -   wherein a plurality of articulation cables extend through the        shaft from the handle to the flexible spine, such that when        tension is applied to at least one of the plurality of        articulation cables, the flexible spine bends;    -   wherein a rotatable element extends through the shaft from the        handle to the end effector, such that when the rotatable element        is rotated, the end effector rotates; and    -   wherein an actuation element extends through the shaft from the        handle to the end effector, such that when the actuation element        is moved, the end effector is actuated.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

obtaining apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a tool comprising:        -   a shaft having a distal end and a proximal end;        -   a handle attached to the proximal end of the shaft; and        -   an end effector attached to the distal end of the shaft;        -   wherein the shaft comprises a flexible portion extending            distally from the proximal end of the shaft, and an            articulating portion extending proximally from the distal            end of the shaft, and wherein the articulating portion            comprises a flexible spine;        -   wherein a plurality of articulation cables extend through            the shaft from the handle to the flexible spine, such that            when tension is applied to at least one of the plurality of            articulation cables, the flexible spine bends;        -   wherein a rotatable element extends through the shaft from            the handle to the end effector, such that when the rotatable            element is rotated, the end effector rotates; and        -   wherein an actuation element extends through the shaft from            the handle to the end effector, such that when the actuation            element is moved, the end effector is actuated; and

using the apparatus to perform a minimally-invasive procedure.

In another form of the invention, there is provided a novel monopolarknife.

And in another form of the invention, there is provided a novel methodfor cutting tissue using a monopolar knife.

In still another form of the invention, there is provided a novelmonopolar knife with flushing capabilities.

And in another form of the invention, there is provided a novel methodfor cutting tissue using a monopolar knife with flushing capabilities.

In one preferred form of the present invention, there is providedapparatus for performing a minimally-invasive procedure, the apparatuscomprising:

a shaft having a distal end and a proximal end;

a monopolar knife assembly attached to the distal end of the shaft, themonopolar knife assembly comprising a knife;

a handle attached to the proximal end of the shaft;

wherein the shaft comprises a flexible portion and an articulatingportion, wherein the flexible portion extends distally from the handleand the articulating portion extends distally from the flexible portion;

wherein at least one articulation cable extends from the handle to thearticulating portion, such that when tension is applied to the at leastone articulation cable, the articulating portion deflects;

wherein an actuation element extends through the shaft from the handleto the knife, such that when the actuation element is moved, the knifeis moved; and

wherein the actuation element transmits electrical power from the handleto the knife.

In another preferred form of the present invention, there is provided amethod for creating a bleb in tissue, the method comprising:

providing apparatus comprising:

-   -   a shaft having a distal end and a proximal end;    -   a monopolar knife assembly attached to the distal end of the        shaft, the monopolar knife assembly comprising a knife;    -   a handle attached to the proximal end of the shaft;    -   wherein the shaft and the handle are configured to so that fluid        can be passed from the handle to the distal end of the shaft and        into tissue;    -   wherein an actuation element extends through the shaft from the        handle to the knife, such that when the actuation element is        moved, the knife is moved; and    -   wherein the actuation element transmits electrical power from        the handle to the knife;

inserting the knife through tissue to be excised; and

injecting fluid into the tissue to lift the tissue to be excised awayfrom underlying tissue.

In another preferred form of the present invention, there is provided amethod for performing a minimally-invasive procedure, the methodcomprising:

providing apparatus for performing a minimally-invasive procedure, theapparatus comprising:

-   -   a shaft having a distal end and a proximal end;    -   a monopolar knife assembly attached to the distal end of the        shaft, the monopolar knife assembly comprising a knife;    -   a handle attached to the proximal end of the shaft;    -   wherein the shaft comprises a flexible portion and an        articulating portion, wherein the flexible portion extends        distally from the handle and the articulating portion extends        distally from the flexible portion;    -   wherein at least one articulation cable extends from the handle        to the articulating portion, such that when tension is applied        to the at least one articulation cable, the articulating portion        deflects;    -   wherein an actuation element extends through the shaft from the        handle to the knife, such that when the actuation element is        moved, the knife is moved; and    -   wherein the actuation element transmits electrical power from        the handle to the knife; and

using the apparatus to perform a minimally-invasive procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing a novel medical instrument formed inaccordance with the present invention;

FIG. 1A is a schematic view showing the handle and proximal end of theshaft of the novel medical instrument shown in FIG. 1 ;

FIG. 1B is a schematic view showing the distal end of the shaft and theend effector of the novel medical instrument shown in FIG. 1 ;

FIGS. 2-23 are schematic views showing further details of the shaft andthe end effector of the novel medical instrument shown in FIG. 1 ;

FIGS. 24-46B are schematic views showing further details of the handleand the proximal end of the shaft of the novel medical instrument shownin FIG. 1 ;

FIGS. 47-55 are schematic views showing a novel tool support which maybe used in conjunction with the novel medical instrument shown in FIG. 1;

FIGS. 56-58F are schematic views showing another novel medicalinstrument formed in accordance with the present invention;

FIGS. 59-62 are schematic views showing another form of end effector forthe novel medical instrument of the present invention;

FIGS. 63-66 are schematic views showing another novel medical instrumentformed in accordance with the present invention;

FIGS. 67-72 are schematic views showing another novel medical instrumentformed in accordance with the present invention;

FIGS. 73 and 74 are schematic views showing another novel medicalinstrument formed in accordance with the present invention;

FIGS. 75 and 76 are schematic views showing another novel medicalinstrument formed in accordance with the present invention;

FIGS. 77-80 are schematic views showing another novel medical instrumentformed in accordance with the present invention;

FIGS. 81-98 are schematic views showing another novel medical instrumentformed in accordance with the present invention;

FIGS. 98A-98F are schematic views of the novel medical instrument ofFIGS. 81-98 being used to create a bleb and cut tissue;

FIG. 99 is a schematic view showing another handle construction that canbe used to deliver monopolar electrical power to an end effector; and

FIGS. 100-108 are schematic views showing another novel medicalinstrument formed in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

1 The Novel Medical Instrument in General

The present invention comprises a novel medical instrument forperforming minimally-invasive procedures. The novel medical instrumentis highly flexible, capable of articulating with a range of differentmotions, and configured for precise control, while being operated (e.g.,along a tortuous path) from only the handle end of the medicalinstrument.

Looking first at FIGS. 1, 1A, 1B and 2 , there is shown a novel medicalinstrument 5 formed in accordance with the present invention. Novelmedical instrument 5 generally comprises a handle 10 and a shaft 15extending distally from handle 10. Shaft 15 generally comprises anelongated, flexible proximal portion 20 and a distal articulatingportion 25 which is mounted to the distal end of flexible proximalportion 20. An end effector 30 is mounted to the distal end of distalarticulating portion 25. End effector 30 may take many different forms(e.g., graspers, injection needles, scissors, hot snares, monopolarprobes, hemostasis clips, bipolar forceps, suction tubes, single-fire ormulti-fire closure devices such as staplers and tackers, dissectorforceps, retrieval baskets, monopolar scissors, monopolar knife,monopolar knife with flushing capabilities, etc.). For clarity ofillustration, end effector 30 is shown in the figures as a grasper.Handle 10 may take any one of many different forms (e.g., a pistol grip,a shaft grip, etc.). For clarity of illustration, handle 10 is shown inthe figures as a pistol grip.

In accordance with the present invention, flexible proximal portion 20of shaft 15 is configured to be a highly flexible element capable ofextending a significant length (e.g., 95 cm-140 cm) along a tortuouspath, distal articulating portion 25 of shaft 15 is configured to becapable of universal articulation relative to the distal end of flexibleproximal portion 20 of shaft 15, and end effector 30 is configured to beselectively rotated relative to the distal end of distal articulatingportion 25 and may be selectively actuated, with all functions able tobe carried out by a single hand of a user via handle 10. In onepreferred form of the invention, substantially the entire shaft 15 ofmedical instrument 5 is flexible, with the portion of shaft 15 proximalto a transition point 32 (i.e., flexible proximal portion 20) beingpassively flexible (e.g., able to follow a tortuous path), and theportion of shaft 15 distal to transition point 32 (i.e., distalarticulating portion 25) being actively flexible (e.g., able to beuniversally articulated to a desired configuration).

As will hereinafter be described in further detail, novel medicalinstrument is capable of at least the following motions:

Motion 1—longitudinal movement of end effector 30 by longitudinalmovement of handle 10 (sometimes referred to herein as a “longitudinalmotion function”);

Motion 2—rotational movement of end effector 30 by rotational movementof handle 10 (sometimes referred to herein as a “torqueing motionfunction”);

Motion 3—articulating movement of end effector 30 relative to handle 10by articulating distal articulating portion 25 of shaft 15 relative tothe distal end of flexible proximal portion 20 of shaft 15 (sometimesreferred to herein as a “universal articulation function”);

Motion 4—rotational movement of end effector 30 relative to the distalend of distal articulating portion 25 of shaft 15 by rotating endeffector 30 relative to shaft 15 (sometimes referred to herein as a“roticulation function”); and

Motion 5—actuation of end effector 30, e.g., selectively moving elementsof end effector 30 relative to one another so as to carry out a medicalprocedure, e.g., opening and closing the jaws of a grasper-type endeffector (sometimes referred to herein as a “jaw open/close function”).

2 Construction of Shaft 15

2.1 Flexible Proximal Portion 20

Looking now at FIGS. 1, 1A, 1B and 2-4 , flexible proximal portion 20 ofshaft 15 generally comprises an elongated flexible outer coil 35 (FIGS.2 and 3 ) having a distal end 40, a proximal end 45 and a lumen 50extending therebetween. Distal articulating portion 25 of shaft 15 ismounted to distal end 40 of outer coil via intervening elements (seebelow). Proximal end 45 of outer coil 35 is secured to a shaft adapter55 which is, in turn, secured to handle 10 (see below).

Means for selectively articulating distal articulating portion 25relative to the distal end of flexible proximal portion 20 (i.e.,relative to distal end 40 of outer coil 35), means for selectivelyrotating end effector 30 relative to distal articulating portion 25, andmeans for selectively actuating end effector 30 extend through lumen 50of outer coil 35, as will hereinafter be discussed in further detail.

In one preferred form of the invention, a rigid tube 60 (FIGS. 1A and 4) is provided at the proximal end of flexible proximal portion 20 (i.e.,disposed about the proximal end 45 of outer coil 35 and secured to shaftadapter 55), whereby to provide a region of increased rigidity formounting novel medical instrument 5 to a tool support (e.g., atable-mounted tool support) as will hereinafter be discussed in furtherdetail. If desired, rigid tube 60 may comprise a fillet 65 (FIG. 4 ) atthe distal end of rigid tube 60 which provides a smooth transitionbetween the outer surface of rigid tube 60 and the outer surface of theportion of flexible proximal portion 20 located distal to rigid tube 60.

2.2 Distal Articulating Portion 25 in General

As discussed above, distal articulating portion 25 is configured toselectively articulate relative to the distal end of flexible proximalportion 20. To this end, and looking now at FIGS. 2 and 5 , distalarticulating portion 25 generally comprises a distal articulation linkassembly 70, a proximal articulation link assembly 75 and a flex spine80 extending between distal articulation link assembly 70 and proximalarticulation link assembly 75. Proximal articulation link assembly 75 isconfigured to be mounted to the distal end of flexible proximal portion20 of shaft 15 and to provide a counterforce surface to enable selectivearticulation of distal articulation link assembly 70 and flex spine 80,as will hereinafter be discussed in further detail.

2.2.1 Proximal Articulation Link Assembly 75

Looking now at FIGS. 2 and 6 , proximal articulation link assembly 75 isdisposed at the distal end 40 of outer coil 35 of flexible proximalportion 20. The distal end of proximal articulation link assembly 75provides a counterforce surface to enable selective flexing of distalarticulation link assembly 70 and flex spine 80 relative to the distalend of flexible proximal portion 20 of shaft 15 (i.e., in order toeffect universal articulation of distal articulating portion 25).

More particularly, proximal articulation link assembly 75 (FIG. 6 )comprises a body 85 having a pair of distally-extending fingers 90 whichare configured to engage flex spine 80 (FIG. 5 ) as will hereinafter bediscussed in further detail. A plurality of bores 95 (FIG. 6 ), disposedabout a central bore 100 (FIG. 18 ), are formed in body 85 and sized toreceive a plurality of articulation cables (see below). If desired,bores 95 may comprise counterbores (not shown) disposed at theirproximal ends for receiving articulation cable housings as willhereinafter be discussed. Central bore 100 (FIG. 18 ) may comprise acounterbore 102 (FIGS. 6 and 18 ) disposed at its distal end forfacilitating mounting of distal articulating link assembly 70 to body85, as will hereinafter be discussed.

Body 85 of proximal articulation link assembly 75 bears against aplurality of articulation cable housings 235 (see below) which, in turn,bear against handle in order for proximal articulation link assembly 75to provide a counterforce surface for selective flexing of distalarticulating portion 25 of shaft 15, as will hereinafter be discussed.Note that outer coil 35 is secured to body 85 of proximal articulationlink assembly 75, but provides substantially no counterforce to body85—the counterforce to body 85 is provided by the articulation cablehousings.

2.2.2 Distal Articulation Link Assembly 70

Looking now at FIGS. 2, 5 and 7 , distal articulation link assembly 70generally comprises a body 105 (FIG. 7 ) having a central opening 110passing therethrough, and a short laser-cut hypotube 115 extendingproximally therefrom. Short laser-cut hypotube 115 comprises a distalend 120, a proximal end 125 and a lumen 130 extending therebetween.Short laser-cut hypotube 115 is configured to be highly flexible, butwith sufficient column strength, so as to permit selective articulationof body 105 relative to proximal articulation link assembly 75 whenproximal end 125 of short laser-cut hypotube 115 bears against body 85(FIG. 6 ) of proximal articulation link assembly 75 and an off-centerproximal force is applied to body 105, as will hereinafter be discussed.Proximal end 125 of short laser-cut hypotube 115 is mounted to body 85of proximal articulation link assembly 75 (e.g., via welding). Distalend 120 of short laser-cut hypotube 115 is mounted to body 105 (e.g.,via welding), with lumen 130 of short laser-cut hypotube 115 beingaligned with central opening 110 of body 105 when distal articulationlink assembly 70 is in its relaxed (i.e., unbiased) condition. As aresult of this construction, rotation of body 85 of proximalarticulation link assembly 75 causes rotation of laser-cut hypotube 115,whereby to cause rotation of body 105 of distal articulation linkassembly 70. Body 105 also comprises a pair of distal seats 135 (onlyone of which is shown in FIG. 7 ) for mounting one or more articulationcables to body 105, as will hereinafter be discussed in further detail.Body 105 also comprises two proximally-extending fingers 137 for matingwith flex spine 80 (FIG. 5 ), as will hereinafter be discussed infurther detail.

2.2.3 Flex Spine 80

Looking now at FIG. 5 , flex spine 80 generally comprises a flexiblebody 140 having a distal end 141 and a proximal end 142. A plurality ofaxially-aligned openings 145, and a central bore 150, extend betweendistal end 141 and proximal end 142. Openings 145 are sized to eachreceive an articulation cable therein as will hereinafter be discussed.Central bore 150 is sized to receive short laser-cut hypotube 115 (FIG.7 ) of distal articulation link assembly 70. Proximal end 142 of flexspine 80 comprises proximal seats 155 for seating the aforementioneddistally-extending fingers 90 (FIG. 6 ) of proximal articulation linkassembly 75, and distal end 141 of flex spine 80 comprises distal seats160 for receiving the aforementioned proximally-extending fingers 137(FIG. 7 ) of distal articulation link assembly 70. It will beappreciated that when flex spine 80 is mounted in this fashion, flexspine 80 is fixed against rotation relative to either distalarticulation link assembly 70 or proximal articulation link assembly 75.

2.2.4 Rotatable Housing Assembly 165

Looking next at FIGS. 5 and 8-12 , the distal end of distal articulatingportion 25 comprises a rotatable housing assembly 165 (FIG. 9 ) forrotatably mounting end effector 30 to distal articulation link assembly70, as will hereinafter be discussed.

More particularly, rotatable housing assembly 165 generally comprises acollar 170, a long laser-cut hypotube 180 having a distal end 185, aproximal end 190 and a lumen 195 extending therebetween. Rotatablehousing assembly 165 also comprises a rotation connector 200 (FIGS. 9and 10 ) having an opening 205 formed therein which is fixedly mountedto distal end 185 of long laser-cut hypotube 180 such that lumen 195 oflong laser-cut hypotube 180 is aligned with opening 205 of rotationconnector 200 when rotatable housing assembly 165 is in its relaxed(i.e., unbiased) condition, and such that long laser-cut hypotube 180and rotation connector 200 can rotate as a unit. An end effector mount210 (FIGS. 8, 9, 11 and 12 ), is mounted to rotation connector 200 suchthat end effector mount 210 rotates when rotation connector 200 rotates(i.e., when long laser-cut hypotube 180 rotates). End effector 30 ismounted to end effector mount 210 (see below). Rotation connector 200and end effector mount 210 are rotatably mounted to body 105 of distalarticulation link assembly 70 (FIGS. 5 and 7 ) via collar 170 (FIG. 5 ).More particularly, rotation connector 200 (FIG. 9 ) is rotatably mountedto collar 170 and is able to rotate relative to collar 170. End effectormount 210 is mounted to rotation connector 200 and engages a distalshoulder 215 (FIG. 10 ) of rotation connector 200. Collar 170 is fixedlymounted to body 105 of distal articulation link assembly 70 (FIG. 7 ).Thus, end effector mount 210 (FIG. 9 ) is fixedly mounted to rotationconnector 200 which is in turn fixedly connected to long laser-cuthypotube 180, and the foregoing subassembly (end effector mount 170,rotation connector 200 and long laser-cut hypotube 180) is rotatablymounted to collar 170, with collar 170 being fixedly mounted to distalarticulation link assembly 70 (FIG. 5 ), and with long laser-cuthypotube 180 extending through central bore 150 of flex spine 80 andthrough bore 100 (FIG. 18 ) of body 85 of proximal articulating linkassembly 75.

2.3 End Effector 30

End effector 30 may take many different forms (e.g., graspers, injectionneedles, scissors, hot snares, monopolar probes, hemostasis clips,bipolar forceps, suction tubes, single-fire or multi-fire closuredevices such as staplers and tackers, dissector forceps, retrievalbaskets, monopolar scissors, monopolar knife, monopolar knife withflushing capabilities, etc.). For clarity of illustration, end effector30 is shown in the figures as a grasper.

In one preferred form of the invention, and looking now at FIG. 8 , endeffector 30 is mounted to end effector mount 210. More particularly, inone preferred form of the invention, end effector 30 comprises a grasperhaving two opposed jaws 216, 217 which are pivotally mounted to endeffector mount 210 via a pin 217A which passes through holes 217B injaws 216, 217 and through holes 217C in end effector mount 210. A clevis218 is mounted to jaws 216, 217 via a pin 218A disposed in slots 218Bformed in the proximal portions of jaws 216, 217 such that reciprocalmovement of a pull wire mounted to clevis 218 (see below) causes theopposing jaws 216, 217 of the grasper to open and close relative to oneanother, as will hereinafter be discussed.

2.4 Articulation Means in General

As discussed above, shaft 15 also comprises (i) means for selectivelyarticulating distal articulating portion 25 (FIG. 2 ) relative toflexible proximal portion 20, (ii) means for selectively rotatingrotatable housing assembly 165 (FIG. 9 ) relative to shaft 15, and hencefor selectively rotating end effector 30 relative to shaft 15, and (iii)means for selectively actuating end effector 30 (FIG. 8 ). All of theforegoing means are actuated via handle 10, as will hereinafter bediscussed.

More particularly, and looking now at FIGS. 13 and 14 , shaft 15generally comprises (i) four articulation cables 220 for selectivelyarticulating distal articulating portion 25 relative to the distal endof flexible proximal portion 20, (ii) an HHS coil 225 (e.g., a hollowhelical strand of the sort sold by Fort Wayne Metals of Fort Wayne,Ind.) for selectively rotating rotatable housing assembly 165 (FIG. 9 )relative to shaft 15, and hence for selectively rotating end effector 30relative to shaft 15, and (iii) a pull wire 230 for selectivelyactuating end effector 30.

2.4.1 Articulation Cables 220

Looking next at FIGS. 13-16 , in a preferred form of the invention, fourarticulation cables 220 run from handle 10 to distal seats 135 (FIGS. 15and 16 ) of distal articulation link assembly 70, with articulationcables 220 extending through bores 95 of body 85 (FIG. 6 ), throughopenings 145 of flex spine 80 (FIG. 5 ) to distal seats 135 of body 105(FIG. 16 ). Articulation cables 220 are preferably each slidablydisposed within an articulation cable housing 235 (FIG. 13 ). The distalends 240 of articulation cable housings 235 are mounted to body 85 (FIG.15 ) of proximal articulation link assembly 75 (i.e., via threadadjusters 330, as will hereinafter be discussed). Articulation cablehousings 235 bear against body 85 of proximal articulation link assembly75 and provide a counterforce to body 85 for articulation of distalarticulating portion 25 of shaft 15 relative to flexible proximalportion 20 of shaft 15. Articulation cable housings 235 also separatearticulation cables 220 from one another and from HHS coil 225, and helpensure smooth sliding movement of articulation cables 220 withinflexible proximal portion 20 of shaft 15 (i.e., over the distancebetween handle 10 and proximal articulation link assembly 75, which maybe substantial in length (e.g., 95 cm-140 cm) and follow a tortuous pathwhen medical instrument 5 is disposed in a patient). If desired, inorder to facilitate mounting the distal ends of articulation cablehousings 235 to the body 85 (FIG. 15 ), the proximal end of each bore 95may comprise a counterbore (not shown) sized to receive the distal end240 of a given articulation cable housing 235.

Looking now at FIGS. 15 and 16 , after articulation cables 220 passdistally through openings 145 (FIG. 5 ) in flex spine 80, articulationcables 220 are attached (e.g., via welding, crimping, etc.) to distalseats 135 of body 105 of distal articulation link assembly 70. By way ofexample but not limitation, two of the articulation cables 220 may beprovided by a single length of cable, with that single length of cablehaving a tube 245 (FIG. 16 ) crimped thereto and with tube 245 beingwelded (or otherwise affixed) to a distal seat 135.

As a result of this construction, by selectively pulling proximally on aproximal end of an articulation cable 220, body 105 (FIG. 7 ) of distalarticulation link assembly 70 can be articulated laterally, whereby toarticulate distal articulating portion 25 of shaft 15. Furthermore, byproviding at least three articulation cables 220, with the three or morearticulation cables being positioned about the perimeter of body 105,substantially universal articulation of distal articulation linkassembly 70 can be achieved, whereby to provide substantially universalarticulation for distal articulating portion 25 of shaft 15.

2.4.2 HHS Coil 225

Looking next at FIGS. 13, 14 and 17 , HHS coil 225 comprises a distalend 250 (FIG. 17 ), a proximal end 255 (FIG. 26 ) and a lumen 260 (FIG.13 ) extending therebetween. In order to facilitate rotation of HHS coil225 within shaft 15, HHS coil 225 is preferably disposed within aflexible, friction-reducing sleeve 267 (FIG. 13 ). More particularly,HHS coil 225 preferably comprises a plurality of filars which are woundand swaged together so as to together form a hollow tubular structure.By way of example but not limitation, HHS coil 225 may comprise a hollowhelical strand of the sort sold by Fort Wayne Metals of Fort Wayne, Ind.In one preferred form of the present invention, HHS coil 225 comprises10 filars which are wound and swaged together into a singular flexiblestructure. Distal end 250 (FIG. 17 ) of HHS coil 225 is mounted to longlaser-cut hypotube 180 (FIG. 17 ) of rotatable housing assembly 165(FIG. 9 ) via a sleeve (or crimp) 265 (FIG. 17 ), such that longlaser-cut hypotube 180 (and hence end effector mount 210 carrying endeffector 30) rotate when HHS coil 225 rotates. It will be appreciatedthat, as a result of this construction, the rotational disposition ofend effector 30 can be adjusted by selectively rotating HHS coil 225,whereby to rotate long laser-cut hypotube 180 and hence end effectormount 210, to which end effector 30 is secured. Significantly, by usingHHS coil 225 and long laser-cut hypotube 180 to transmit torque downshaft 15, any build-up of torqueing spring energy within the shaft isminimized, even when shaft 15 follows a tortuous path and distalarticulating portion 25 has been articulated relative to thelongitudinal axis of shaft 15.

2.4.3 Pull Wire 230

Looking next at FIGS. 13, 14, 18 and 19 , pull wire 230 is provided forselectively actuating end effector 30. The distal end of pull wire 230(FIG. 19 ) is secured to clevis 218 of end effector 30, with clevis 218being slidably mounted to jaws 216, 217 of end effector 30, and withjaws 216, 217 being pinned to end effector mount 210, such thatreciprocal movement of pull wire 230 causes the opposing jaws 216, 217of end effector 30 to open and close relative to one another.

2.5 Further Details on the Construction of Shaft 15

When shaft 15 is fully assembled, and looking now at FIGS. 18-23 , body85 (FIG. 18 ) of proximal articulation link assembly 75 (FIG. 6 ) ismounted to distal end 40 (FIG. 2 ) of flexible outer coil 35, withdistal ends 240 (FIG. 15 ) of articulation cable housings 235 beingmounted to body 85 of proximal articulation link assembly 75, and witharticulation cables 220 passing through bores 95 (FIG. 6 ) formed inbody 85. Distal articulation link assembly 70 (FIG. 7 ) is mounted toproximal articulation link assembly 75 by mounting proximal end 125 ofshort laser-cut hypotube 115 in counterbore 102 (FIG. 6 ) of body 85.Flexible body 140 (FIG. 5 ) of flex spine 80 is “sandwiched” betweenbody 105 (FIG. 7 ) of distal articulation link assembly 70 and body 85(FIG. 6 ) of proximal link assembly 75, with distally-extending fingers90 of body 85 being disposed in proximal seats 155 (FIG. 5 ) of flexspine 80 and with proximally-extending fingers 137 of body 105 beingdisposed in distal seats 160 of flex spine 80. Short laser-cut hypotube115 (FIG. 7 ) of distal articulation link assembly 70 passes throughcentral bore 150 (FIG. 5 ) of flexible body 140 of flex spine 80. Whenarticulation cables 220 are pulled proximally, the distal end of shortlaser-cut hypotube 115 bears against body 85 of proximal articulationlink assembly 75 (which, in turn, bears against articulation cablehousings 235), whereby to selectively articulate distal articulatingportion 25 of shaft 15.

Long laser-cut hypotube 180 (FIGS. 9, 10 and 17 ) of rotatable housingassembly 165 extends proximally through short laser-cut hypotube 115(FIG. 18 ) such that the proximal end 190 (FIG. 17 ) of long laser-cuthypotube 180 passes through body 85 of proximal articulation linkassembly 75 (i.e., by passing through counterbore 102 and central bore100 of body 85) and is secured to HHS coil 225 (FIG. 17 ), e.g., viasleeve 265. Collar 170 (FIG. 18 ) of rotatable housing assembly 165(FIG. 9 ) is mounted to body 105 of distal articulation link assembly 70and covers distal seats 135 (and the portions of articulation cables 220mounted thereto). Rotation connector 200 (FIGS. 9 and 10 ) is mounted tothe distal end of long laser-cut hypotube 180. Rotation connector 200 isalso mounted to end effector mount 210. End effector 30 is mounted toend effector mount 210. As a result of this construction, when HHS coil225 is rotated, long laser-cut hypotube 180 is rotated and rotationconnector 200 is rotated and end effector mount 210 is rotated, wherebyto cause rotation of end effector 30.

Pull wire 230 (FIG. 18 ) extends distally through lumen 260 of HHS coil225 (FIGS. 13 and 14 ) and distally through lumen 195 (FIG. 9 ) of longlaser-cut hypotube 180, exiting rotation connector 200. The distal endof pull wire 230 is connected to end effector 30. As a result of thisconstruction, reciprocal movement of a pull wire 230 causes the opposingjaws 216, 217 (FIG. 8 ) of the grasper to open and close relative to oneanother.

Flexible proximal portion 20 of shaft 15 is preferably covered with aprotective sleeve or outer covering (e.g., Pebax®) 270 (FIGS. 18, 20 and21 ), with the proximal end of protective sleeve or outer covering 270being secured (e.g., bonded) to rigid tube 60 and with the distal end ofprotective sleeve or outer covering 270 being secured (e.g., bonded) tobody 85 of proximal articulation link assembly 75, and distalarticulating portion 25 of shaft 15 is preferably covered with aprotective sleeve or outer covering 275 (FIGS. 18 and 22 ), with theproximal end of protective sleeve or outer covering 275 being secured tobody 85 of proximal articulation link assembly 75 and with the distalend of protective sleeve or outer covering 275 extending up to and overthe proximal portion of end effector 30, whereby to protect shaft 15 andpermit easy insertion of shaft 15 into the body of a patient via anatural body orifice, a cannula, the lumen of another surgicalinstrument, etc.

The proximal end of shaft 15 is mounted to handle 10 (FIG. 1 ) such thatarticulation cables 220, HHS coil 225 and pull wire 230 may beselectively actuated using handle 10, as will hereinafter be discussedin further detail.

3 Handle 10 in General

Looking now at FIGS. 24-26 , handle 10 generally comprises an internalcavity 280, an articulation control assembly 285 for selectively movingarticulation cables 220 (and hence selectively articulating distalarticulating portion 25 of shaft 15), a push rod lock assembly 290 forselectively locking articulation control assembly 285 in a desiredposition (and hence locking distal articulating portion 25 of shaft 15in a selected position), a roticulation control assembly 295 forselectively rotating HHS coil 225 (and hence selectively rotating endeffector 30), and a trigger assembly 300 for selectively actuating pullwire 230 (and hence selectively actuating end effector 30).

3.1 Articulation Control Assembly 285

Looking now at FIGS. 27-36 , articulation control assembly 285 generallycomprises a ball plate 305 (FIG. 28 ) fixedly mounted within internalcavity 280 of handle 10, a thumbstick ball assembly 310 configured to beselectively pivoted relative to ball plate 305, and a thumbstick 315configured to be engaged by the thumb of a user.

Ball plate 305 comprises a plurality of threaded openings 320 (FIG. 28 )and a center opening 325 for receiving pushrod lock assembly 290, aswill hereinafter be discussed in further detail. Threaded openings 320are configured to receive a plurality of threaded adjusters 330 (FIGS.29 and 30 ) which are, in turn, mounted to the proximal ends (FIGS. 21and 30 ) of each articulation cable housing 235. It will be appreciatedthat, as a result of this construction, the proximal ends ofarticulation cable housings 235 bear against ball plate 305 (which is,in turn, fixedly mounted to handle 10), such that articulation cablehousings 235 can provide a counterforce to body 85 of proximalarticulation link assembly 75 when articulation cables 220 are pulledproximally. Each threaded adjuster 330 comprises a central lumen passingtherethrough, such that an articulation cable 220 (FIG. 30 ) may passthrough the threaded adjuster (and hence, through threaded openings 320of ball plate 305) to be mounted to thumbstick ball assembly 310, aswill hereinafter be discussed. An enlargement 335 (FIG. 30 ) is formedon (or attached to) the proximal end of each articulation cable 220,whereby to facilitate mounting articulation cables 220 to thumbstickball assembly 310. Ball plate 305 also comprises a proximally-facingconcave recess 340 (FIG. 29 ) for providing clearance to thumbstick ballassembly 310 which is pivotally seated within a seat 342 disposed withininternal cavity 280 of handle 10, as will hereinafter be discussed infurther detail.

Thumbstick ball assembly 310 comprises a hemispherical distal ball 345(FIG. 32 ) and a hemispherical proximal ball 350. Hemispherical distalball 345 preferably has a maximum diameter (i.e., the diameter at itsproximal end) which is greater than the maximum diameter ofhemispherical distal ball 345 (i.e., the diameter at its distal end),whereby to provide a proximal circumferential seat 355 (FIG. 31 ) aboutthe proximal end of hemispherical distal ball 345. A plurality ofopenings (or grooves) 360 (FIG. 31 ) are formed in the proximalcircumferential seat 355 for receiving articulation cables 220 whenenlargements 335 are seated on proximal circumferential seat 355, aswill hereinafter be discussed. As a result of this construction, whenthe rounded distal end of hemispherical distal ball 345 is pivotallydisposed within seat 342 in internal cavity 280 of handle 10 (FIG. 27 )and spaced from ball plate 305 (FIG. 33 ), articulation cables 220 maybe passed through openings (or grooves) 360 in proximal circumferentialseat 355 as enlargements 335 seat on proximal circumferential seat 355.Hence, articulation cables 220 may be selectively moved by selectivelypivoting hemispherical distal ball 345 within its seat 342 insideinternal cavity 280 of handle 10 (i.e., by selectively pivotingthumbstick 315, as will hereinafter be discussed in further detail).

Thumbstick 315 comprises a threaded stem 362 (FIG. 33 ) and a thumb seat363. The distal end of threaded stem 362 secures hemispherical proximalball 350 to hemispherical distal ball 345. Thumb seat 363 is secured tothe proximal end of threaded stem 362. As a result of this construction,thumbstick 315 can be used to selectively move hemispherical distal ball345, whereby to selectively move articulation cables 220, whereby toselectively articulate distal articulating portion 25 of shaft 15relative to flexible proximal portion 20 of shaft 15.

3.1.1 Push Rod Lock Assembly 290

Looking next at FIGS. 27, 28 and 33-36 , pushrod lock assembly 290generally comprises an actuation lever 365 (FIG. 33 ), a cam 370 mountedto actuation lever 365, and a pushrod lock assembly plate 375 having apushrod 380 mounted thereto and extending proximally therefrom. Pushrod380 is preferably disposed within a sleeve 385. In one preferred form ofthe invention, a spring 390 (FIG. 35 ) is disposed over sleeve 385 so asto bias pushrod lock assembly plate 375 distally away from ball plate305 (FIG. 36 ). Pushrod 380 is slidably disposed in center opening 325(FIG. 28 ) of ball plate 305 and extends proximally therefrom towardthumbstick ball assembly 310 (FIG. 33 ). Actuation lever 365 and cam 370are rotatably mounted within cavity 280 of handle 10, with cam 370contacting pushrod lock assembly plate 375 such that movement ofactuation lever 365 cams pushrod lock assembly plate 375 (and hencepushrod 380) proximally against the power of spring 390, whereby tocause the free end of pushrod 380 to engage hemispherical distal ball345, thereby locking thumbstick ball assembly 310 against movement. Whenactuation lever 365 is moved in a second, opposite direction, cam 370 ismoved so as to allow pushrod lock assembly plate 375 (and hence pushrod380) to move distally under the power of spring 390, away fromhemispherical distal ball 345, whereby to allow free movement ofthumbstick ball assembly 310. As a result, it will be appreciated thatpushrod lock assembly 290 can be used to selectively lock thumbstickball assembly 310 in a desired position, whereby to selectively lockdistal articulating portion 25 of shaft 15 in a desired (e.g.,articulated) configuration.

3.2 Roticulation Control Assembly 295

Looking next at FIGS. 37-41 , roticulation control assembly 295generally comprises a roticulation knob 395 (FIGS. 37 and 38 ) having akeyway 400 (FIG. 38 ) passing therethrough, and a roticulation key 405.Roticulation key 405 comprises a distal end 406, a proximal end 407 anda lumen 408 extending therebetween. HHS coil 225 is received withinlumen 408 of roticulation key 405 and is secured to roticulation key 405such that rotation of roticulation key 405 effects rotation of HHS coil225. As noted above, HHS coil 225 is secured to long laser-cut hypotube180, and long laser-cut hypotube 180 is secured to end effector mount210, such that rotation of HHS coil 225 causes rotation of longlaser-cut hypotube 180 which causes rotation of end effector mount 210(and hence rotation of end effector 30). Distal end 406 ofrotaticulation key 405 is received in keyway 400 of roticulation knob395 such that roticulation key 405 is engaged by roticulation knob 395and rotates when roticulation knob 395 rotates. As a result of thisconstruction, rotation of roticulation knob 395 causes rotation ofroticulation key 405 which causes rotation of HHS coil 225 and hencerotation of end effector 30. In a preferred form of the invention,keyway 400 of roticulation knob 395 comprises a non-circularcross-sectional profile which matches the non-circular cross-sectionalprofile of distal end 406 of roticulation key 405.

Roticulation knob 395 is rotatably mounted within cavity 280 of handle10 such that a portion of roticulation knob 395 protrudes out of handle10 (FIG. 37 ), whereby to permit roticulation knob 395 to be selectivelyrotated by a user. Pull wire 230 (FIG. 40 ), which is disposed withinHHS coil 225, extends through roticulation key 405 and is selectivelyactuated using trigger assembly 300 (FIG. 25 ), as will hereinafter bediscussed.

Proximal end 407 of roticulation key 405 extends out of roticulationknob 395 (FIG. 39 ). In one preferred form of the present invention,proximal end 407 (FIG. 38 ) of roticulation key 405 comprises aplurality of teeth 409 for releasably engaging a ball nose springplunger 410 (FIG. 41 ). Ball nose spring plunger 410 is mounted withincavity 280 of handle 10 such that ball nose spring plunger 410releasably engages teeth 409 disposed on proximal end 407 ofroticulation key 405. By virtue of the engagement between ball nosespring plunger 410 and roticulation key 405, roticulation key 405 (andhence HHS coil 225 which is mounted to roticulation key 405) areprevented from “spontaneously” rotating absent deliberate rotation ofroticulation knob 395. Thus, ball nose spring plunger 410 preventsaccumulated spring tension (e.g., spring tension which can build up whenrotating HHS coil 225 using roticulation knob 395) from “unraveling” HHScoil 225 and thereby causing unintentional rotation of HHS coil 225 (andhence unintentional rotation of end effector 30).

3.3 Trigger Assembly 300

Looking next at FIGS. 42-46, 46A, 46B and 47 , trigger assembly 300generally comprises a trigger 415 pivotally mounted to handle 10, a sled420 (FIG. 43 ) movably disposed within cavity 280 of handle 10, and oneor more lever arms 425 which connect trigger 415 to sled 420 such thatwhen trigger 415 is actuated (i.e., pulled), sled 420 moves proximallywithin cavity 280 of handle 10, whereby to move pull wire 230proximally, whereby to actuate end effector 30, as will hereinafter bediscussed in further detail.

More particularly, sled 420 comprises a cavity 430 (FIG. 45 ), a distalbushing 435 (FIG. 46 ) disposed within cavity 430, a proximal bushing440 disposed within cavity 430, and a spring 445 disposed between distalbushing 435 and proximal bushing 440. An inner support tube 450 issecured to pull wire 230 (e.g., by a crimp sleeve 451 disposed at theproximal end of inner support tube 450). An outer support tube 452 isdisposed over the distal portion of inner support tube 450, with innersupport tube 450 able to slide freely within outer support tube 452.Outer support tube 452 also comprises an outer support tube collar 453which is sized to be mounted within a seat 454 (FIG. 46B) formed ininternal cavity 280 of handle 10. A spring 455 (FIG. 42 ) is disposed inthe proximal end of handle 10 so as to bias sled 420 distally.

As a result of this construction, when sled 420 is moved proximally(i.e., by pulling trigger 415) against the power of spring 455 (FIG. 42), distal bushing 435 (FIG. 46 ) moves proximally, bearing againstspring 445 which, in turn, bears against proximal bushing 440, whichbears against crimp sleeve 451 and pulls pull wire 230 proximally. Thus,as sled 420 moves proximally, proximal bushing 440 and crimp sleeve 451also move proximally, whereby to move pull wire 230 proximally andthereby actuate end effector 30. It should be appreciated, however, thatinasmuch as sled 420 is not mounted directly to pull wire 230, proximalbushing 440 and spring 445 act as a force limiter, with spring 445yielding when the force on pull wire 230 exceeds a given level, wherebyto cease applying a proximal force to pull wire 230. Put another way, ifthe force applied to move sled 420 proximally exceeds the force biasingproximal bushing 440 away from distal bushing 435 (i.e., the biasingforce provided by spring 445), spring 445 will compress, therebyallowing proximal bushing 440 and crimp sleeve 451 (and hence innersupport tube 450 and pull wire 230) to remain stationary as sled 420moves proximally. In this way trigger 415 can be pulled through a “fullstroke” without the danger of breaking pull wire 230.

It should also be appreciated that since spring 455 biases sled 420distally, and since crimp sleeve 451 is engaged by a shoulder 456 whensled 420 moves proximally, sled 420 will return to its distal positionwithin handle 10 and pull wire 230 will be moved distally.

4 Exemplary Method of Use

In an exemplary use of novel medical instrument 5 in aminimally-invasive procedure, the profile of end effector 30 is reduced(e.g., where end effector 30 comprises a grasper, the jaws of thegrasper are closed); shaft 15 is straightened; handle 10 islongitudinally advanced so as to longitudinally advance the distal endof medical instrument 5 through a portal and into the body (e.g., alonga tortuous path); handle 10 is longitudinally advanced and/or rotated,and/or distal articulating portion 25 of shaft 15 is bent and/or endeffector 30 is roticulated, so that end effector 30 appropriatelyaddresses the target tissue at the internal site; end effector 30 isused to perform the desired procedure (e.g., where end effector 30comprises a surgical grasper the jaws of the grasper are opened andclosed to grasp tissue) at the internal site; and the distal end ofmedical instrument 5 is withdrawn from the body, e.g., handle 10 islongitudinally withdrawn through the portal (during which the handle mayalso be rotated, and/or distal articulating portion 25 of shaft 15 isunbent and/or the end effector roticulated as necessary), so that theend effector is withdrawn from the body.

It will be appreciated that novel medical instrument 5 is capable of atleast the following motions:

Motion 1—longitudinal movement of end effector 30 by longitudinalmovement of handle 10 (sometimes referred to herein as a “longitudinalmotion function”);

Motion 2—rotational movement of end effector 30 by rotational movementof handle 10 (sometimes referred to herein as a “torqueing motionfunction”);

Motion 3—articulating movement of end effector 30 relative to handle 10by articulating distal articulating portion 25 of shaft 15 relative tothe distal end of flexible proximal portion 20 of shaft 15 (sometimesreferred to herein as a “universal articulation function”);

Motion 4—rotational movement of end effector 30 relative to the distalend of distal articulating portion 25 of shaft 15 by rotating endeffector 30 relative to shaft 15 (sometimes referred to herein as a“roticulation function”); and

Motion 5—actuation of end effector 30, e.g., selectively moving elementsof end effector 30 relative to one another so as to carry out a medicalprocedure, e.g., opening and closing the jaws of a grasper-type endeffector (sometimes referred to herein as a “jaw open/close function”).

It will be appreciated by those skilled in the art that, if desired, themedical instrument may be modified so as to provide less (or more) thanthe five aforementioned motions, e.g., the roticulation function may beeliminated, an additional rotational function such as selective rotationof shaft 15 may be added, etc.

5 Novel Tool Support

Looking next at FIGS. 47-49 , there is shown a novel tool support 460which may be used to support medical instrument 5. Tool support 460generally comprises a clamp 465 for mounting tool support 460 to asurgical table 466, an adjustable base 470 for mounting one or moremedical instrument(s) 5 to tool support 460, and an adjustable arm 475(FIG. 48 ) for adjustably mounting base 470 to clamp 465. One or moreinstrument adapters 480 (FIG. 49 ) are mounted to base 470, whereby topermit mounting of one or more medical instrument(s) 5 to tool support460 (i.e., by providing a support for handle 10 and/or rigid tube 60 atthe proximal end of shaft 15), as will hereinafter be discussed infurther detail.

One or more tool channels 485, configured for passing shaft 15 into apatient (or into the working lumen of another medical instrument), aremounted to the one or more instrument adapters 480, as will hereinafterbe discussed in further detail.

More particularly, and still looking at FIGS. 47-50 , clamp 465 isconfigured to be mounted to a stable object (e.g., to surgical table466) in order to permit a surgeon to manipulate tool support 460 (andhence the one or more medical instruments 5 mounted thereto) relative tothe patient and/or relative to other surgical instruments, as willhereinafter be discussed.

Adjustable arm 475 preferably comprises one or more segments 490 (FIG.49 ) which are adjustably mounted to one another, and to clamp 465 andto base 470, whereby to permit the surgeon to precisely adjust thedisposition of base 470 relative to the patient (and/or relative toanother surgical instrument).

Looking now at FIGS. 49 and 50 , instrument adapters 480 each comprise amount 495 and a tube 500. Mount 495 is pivotally mounted to base 470(FIG. 49 ). Tube 500 has a lumen 505 sized to receive the proximal endof shaft 15 of medical instrument 5 (i.e., rigid tube 60 located at theproximal end of shaft 15). If desired, lumen 505 may comprise a septum515 for fluidically sealing tube 500 (and hence fluidically sealing toolchamber 485), and/or tube 500 may comprise an end cap 520 forfluidically sealing tube 500 (and hence, for fluidically sealing toolchamber 485).

Looking now at FIGS. 51-55 , there are shown some exemplaryconfigurations for tool support 460. It should be appreciated that base470 of tool support 460 may comprise a plurality of pivots and/or arms,may be shaped in the form of an arc, and/or may comprise othergeometries, etc., in order to accommodate the needs and/or preferencesof the surgeon.

6 Medical Instrument 5 with Rotatable Shaft 15

As discussed above, novel medical instrument 5 comprises a shaft 15having a flexible proximal portion 20, a distal articulating portion 25which can be selectively articulated relative to the distal end offlexible proximal portion 20, and an end effector 30 which can beselectively rotated relative to the distal end of distal articulatingportion 25. With this construction, longitudinal movement of handle 10can be used to move shaft 15 distally and proximally, whereby to moveend effector 30 distally and proximally; rotational movement of handle10 can be used to rotate shaft 15, whereby to rotate end effector 30;articulation control assembly 285 (FIG. 25 ) can be used to articulatedistal articulating portion 25 of shaft 15, whereby to redirect endeffector 30; roticulation control assembly 295 (FIG. 25 ) can be used torotate end effector 30; and trigger assembly 300 (FIG. 25 ) can be usedto actuate end effector 30. With the foregoing construction, flexibleproximal portion 20 rotates as a unit with handle 10.

However, it has been recognized that it may be desirable to be able torotate flexible proximal portion 20 of shaft 15 independently of handle10. To this end, and looking now at FIGS. 56-58 , a novel rotatableshaft adapter mechanism 525 may be provided between shaft 15 and handle10, whereby to allow shaft 15 (i.e., both flexible proximal portion 20and distal articulating portion 25) to be selectively rotated relativeto handle 10.

More particularly, rotatable shaft adapter mechanism 525 is mounted tothe proximal end of shaft 15 (i.e., mounted to the proximal end offlexible proximal portion 20) and connects shaft 15 to handle 10. Itshould be appreciated that, in this form of the invention, rotatableshaft adapter mechanism 525 replaces the aforementioned shaft adapter 55(where the aforementioned shaft adapter 55 was fixedly secured to handle10 and fixedly secured to the proximal end of outer coil 35, and whererigid tube 60 was fixedly secured to shaft adapter 55). Moreparticularly, in this form of the invention, shaft 15 is rotatablymounted to the distal end of handle 10 and selectively locked/unlockedfrom rotation via rotatable shaft adapter mechanism 525, as willhereinafter be discussed in further detail.

Still looking now at FIGS. 56-58 , in this form of the invention, rigidtube 60 of shaft 15 comprises a flange 530 disposed around theproximalmost end of rigid tube 60. Flange 530 is received within acorresponding groove 535 formed in the distal end of handle 10 (i.e.,formed within cavity 280 of handle 10 near the distalmost end of handle10), whereby to rotatably mount rigid tube 60 of shaft 15 to handle 10.In this form of the invention, the proximal end of outer coil 35 isfixedly secured to rigid tube 60 (and the distal end of outer coil 35 issecured to body 85 of proximal articulation link assembly 75). The outercircumference of the distalmost end of handle 10 comprises a pluralityof keyways 540 (FIG. 57 ) which are sized to receive a plurality ofprojections 542 formed on rotatable shaft adapter mechanism 525, as willhereinafter be discussed in further detail. Note that, if desired, thelocations of keyways 540 and projections 542 may be reversed from theforegoing, i.e., keyways 540 may be formed on rotatable shaft adaptermechanism 525 and projections 542 may be formed on the distalmost end ofhandle 10.

Rotatable shaft adapter mechanism 525 generally comprises a shaftrotation knob 545 having a lumen 550 extending therethrough. Lumen 550comprises a distal end 555, a proximal end 560 and an annular shoulder565 disposed therebetween. A spring 570 is disposed within distal end555 of lumen 550, extending between annular shoulder 565 and theproximal end 575 of a retaining cap 580 (FIGS. 58, 58A, 58B, 58C and58D) which is mounted circumferentially about the outer perimeter ofshaft 15, whereby to bias shaft rotation knob 545 proximally, so thatprojections 542 of shaft adapter mechanism 525 are received withinkeyways 540 of handle 10, whereby to lock shaft rotation knob 545against rotation. More particularly, retaining cap 580 comprises a pairof flats 585 which key to corresponding flats 590 formed on the outersurface of rigid tube 60 of shaft 15. One or more spring fingers 591engage a groove 592 on the outer surface of rigid tube 60, whereby tolock retaining cap 580 to rigid tube 60. Retaining cap 580 alsocomprises a plurality of key features 593 sized to be received incorresponding keyways 594 of shaft rotation knob 545. As a result ofthis construction, rotation knob 545 is able to slide longitudinally(distally or proximally) relative to rigid tube 60 of shaft 15, however,rotation knob 545 is locked against rotation relative to rigid tube 60(and hence, relative to shaft 15). Therefore, rotation knob 545 can bemoved longitudinally without causing longitudinal motion of rigid tube60 and shaft 15, but rotation of rotation knob 545 will be transferredto rigid tube 60 (and to shaft 15 as will hereinafter be discussed).

Shaft rotation knob 545 is connected to rigid tube 60 of shaft 15 (e.g.,via projections, a friction fit, etc.) so that shaft rotation knob 545is longitudinally movable relative to rigid tube 60 but rotationallyfixed to rigid tube 60.

In this form of the invention, the proximal end of protective sleeve orouter covering (e.g., Pebax®) 270 is secured (e.g., bonded) to rigidtube 60 and the distal end of protective sleeve or outer covering 270 issecured (e.g., bonded) to body 85 of proximal articulation link assembly75. Significantly, protective sleeve or outer covering 270 is capable oftransmitting torque between rigid tube 60 and body 85 of proximalarticulation link assembly 75.

As a result of this construction, spring 570 normally biases shaftrotation knob 545 proximally, whereby to cause projections 542 to engagekeyways 540 and lock shaft 15 against rotation relative to handle 10.However, when shaft rotation knob 545 is moved distally, against thepower of spring 570, projections 542 disengage from keyways 540, therebyallowing shaft rotation knob 545 to be selectively rotated relative tohandle 10, whereby to selectively rotate rigid tube 60 relative tohandle 10, whereby to selectively rotate protective sleeve or outercovering 270 relative to handle 10, whereby to selectively rotate body85 of proximal articulation link assembly 75, whereby to selectivelyrotate distal articulating portion 25 of shaft 15 relative to handle 10.When shaft 15 has been rotated to the desired position relative tohandle 10, shaft rotation knob 545 is released and shaft rotation knob545 moves proximally under the power of spring 570 such that projections542 re-engage keyways 540, thereby locking shaft 15 against furtherrotation relative to handle 10.

Thus it will be seen that in this form of the invention, rigid tube 60is rotatable relative to handle 10 but longitudinally fixed relative tohandle 10; shaft rotation knob 545 is connected to rigid tube 60 suchthat shaft rotation knob 545 can be moved longitudinally relative torigid tube 60 but not rotationally relative to rigid tube 60, such thatshaft rotation knob 545 can be selectively locked to, or unlocked from,handle 10 so as to permit shaft rotation knob 545 to selectively rotaterigid tube 60; and protective sleeve or outer covering 270 transmitstorque between rigid tube 60 and body 85 of proximal articulation linkassembly 75, such that rotation of rigid tube 60 causes rotation of body85 of proximal articulation link assembly 75, whereby to rotate distalarticulating portion 25 of shaft 15 relative to handle 10.

It will be appreciated that unlimited rotation of rigid tube 60 andshaft 15 will cause articulation cables 220 and articulation cablehousings 235 to wind on themselves; therefore, in one preferred form ofthe present invention, means are provided for limiting rotation of rigidtube 60 and shaft 15. More particularly, in one preferred form of theinvention, and looking now at FIGS. 58E and 58F, rigid tube 60 of shaft15 preferably comprises a groove 595 extending partiallycircumferentially about the outer surface of shaft 15. Groove 595 isdisposed just distal to the proximal end of shaft 15 and extendspartially, but not entirely, around the circumference of shaft 15. Acorresponding boss 596 is formed on the distal end of handle 10 andreceived within groove 595. As a result of this construction, shaft 15can be rotated only until boss 596 reaches one end of groove 595. In apreferred form of the present invention, groove 580 is sized so thatshaft 15 can be rotated up to 350 degrees.

7 Additional Constructions

In the foregoing disclosure, there is described a novel medicalinstrument comprising a handle, an elongated flexible shaft and an endeffector disposed at the distal end of the shaft configured forperforming a medical procedure. It should be appreciated that medicalinstrument 5 may be modified in a variety of ways in order to supportdifferent types of end effectors, to facilitate single-handed use ofmedical instrument 5, to enhance the functionality of medical instrument5, etc.

7.1 Alternative End Effector

As discussed above, in a preferred form of the present invention, endeffector 30 comprises a surgical grasper having two opposed jaws 216,217 (FIG. 8 ).

In another preferred form of the present invention, and looking now atFIGS. 59-62 , end effector 30 comprises scissors 600 having opposingblades 605, 610. Blades 605, 610 comprise sharp edges that contact oneanother in order to facilitate cutting (e.g., of tissue, suture, etc.)when blades 605, 610 are brought together (i.e., closed). In order toensure clean cutting by blades 605, 610, it is desirable to maintainblades 605, 610 in tight contact with one another as blades 605, 610 arebrought together (i.e., closed). To this end, a beveled washer 615(FIGS. 61 and 62 ) is disposed between one of the blades 605, 610 andthe inner wall of end effector mount 210. Beveled washer 615 ispreferably disposed over the pin 217A which pivotally mounts blades 605,610 to end effector mount 210. By mounting beveled washer 615 in thismanner, blades 605, 610 are kept in tight engagement as they are broughttogether (i.e., closed), whereby to facilitate clean cutting (e.g., oftissue, of suture, etc.).

7.2 Finger Slide for Single-Handed Shaft Rotation

As discussed above, in one form of the present invention, shaft 15 isrotatably mounted to the distal end of handle 10 and can be selectivelyrotated using rotatable shaft adapter mechanism 525 (FIGS. 56-58 and58A-58F). With this form of the invention, the proximal end of shaft 15is rotationally mounted to the distal end of handle 10 (e.g., by meansof the aforementioned flange 530 (FIG. 58 ) on rigid tube 60 beingrotationally received within the aforementioned corresponding groove 535formed in the distal end of handle 10), and rotatable shaft adaptermechanism 525 is moved distally (i.e., pushed distally by the useragainst the power of spring 570) in order to “unlock” shaft 15 (i.e., toallow shaft rotation knob 545, and hence shaft 15, to rotate). A usercan then rotate shaft 15 as desired (i.e., by rotating rotatable shaftadapter mechanism 525, and hence rotating shaft 15). After the user hasrotated shaft 15 as desired, shaft adapter mechanism 525 is released andautomatically moves proximally (i.e., under the power of spring 570) soas to “lock” shaft 15 against further rotation. This action typicallyrequires that the user use one hand to push rotatable shaft adaptermechanism 525 distally (and thereafter rotate shaft 15) while the useruses their other hand to keep handle 10 stationary.

However, it should be appreciated that it may also be desirable for auser to rotate shaft 15 using a single hand. To this end, in anotherform of the present invention, shaft 15 is kept stationary (e.g., viafriction between the outer surface of shaft 15 and the interior of atool channel (e.g., tool channel 485 (FIG. 48 ), the lumen of a toolchannel provided in another medical instrument such as an endoscope,etc.), handle 10 is selectively rotationally de-coupled from shaft 15,and handle 10 is selectively rotated by a user to a desired rotationalposition using a single hand. Handle 10 is then rotationally re-coupledto shaft 15 and then rotated by the user (whereby to also rotate shaft15).

More particularly, with this form of the invention, and looking now atFIGS. 63-66 , a shaft rotation finger slide assembly 625 is provided inorder to enable single-handed rotation of shaft 15, as will hereinafterbe discussed in further detail. Shaft rotation finger slide assembly 625generally comprises a finger slide mechanism 630 which is slidablydisposed within handle 10, and a shaft collar 635 which is fixedlymounted to the proximal end of shaft 15 (e.g., fixedly mounted to rigidtube 60).

Finger slide mechanism 630 comprises a saddle 640 having a pair ofprojections 645 extending through corresponding slots (not shown) formedin the side wall of handle 10. A pair of finger slides 647 are securedto projections 645. A post 650 extends distally from saddle 640 and isconfigured to selectively lock shaft collar 635 against rotation, aswill hereinafter be discussed in further detail. A spring 655 biasessaddle 640 (and hence post 650) distally, such that post 650 engagesshaft collar 635 when finger slide mechanism 630 is in its restingstate, as will hereinafter be discussed in further detail.

Shaft collar 635 is fixedly mounted to the proximal end of shaft 15(e.g., to rigid tube 60). Shaft collar 635 comprises a distal end 660, aproximal end 665 and a lumen 670 extending therebetween. A plurality ofteeth 675 are disposed about the inside perimeter of lumen 670 atproximal end 665 of shaft collar 635, with teeth 675 being spaced suchthat post 650 of finger slide mechanism 630 can be received within thegap between a pair of adjacent teeth 675, whereby to lock shaft collar635 (and hence shaft 15) against rotation, as will hereinafter bediscussed in further detail.

When a user desires to rotate shaft 15, the user moves finger slides 647proximally, whereby to move projections 645 proximally, whereby to movesaddle 640 proximally against the power of spring 655. As this occurs,post 650 is also moved proximally, whereby to disengage post 650 fromteeth 675 of shaft collar 635 (and thereby rotationally de-couple handle10 from shaft 15). While holding projections 645 proximally, the usercan then rotate handle 10 as desired relative to shaft 15. Shaft 15 doesnot rotate as handle 10 is rotated (i.e., shaft 15 is maintainedstationary by virtue of friction between the outer surface of shaft 15and the interior of the lumen that shaft 15 is disposed in, e.g., toolchannel 485). After the user has rotated handle 10 to the desireddegree, the user releases finger slides 647, which allows projections645 and saddle 640 (and hence post 650) to move distally under the powerof spring 655, with post 650 moving distally into a space between a pairof teeth 675 of shaft collar 635, whereby to rotationally re-couplehandle 10 to shaft collar 635 (and hence shaft 15). At this point, theuser can rotate handle 10 as desired in order to rotate shaft 15. By wayof example but not limitation, if a user desires to rotate shaft 15clockwise 90 degrees, the user can rotationally de-couple shaft 15 fromhandle 10 in the manner discussed above, rotate handle 10counterclockwise 90 degrees (e.g., rotate the grip of handle 10 from the“6 o'clock” position to the “3 o'clock” position), re-couple shaft 15 tohandle 10 in the manner discussed above, and then rotate handle 10 (andhence shaft 15) clockwise 90 degrees (e.g., rotate the grip of handle 10from the “3 o'clock” position to the “6 o'clock” position).

7.3 Single-Plane Articulation Mechanism

As discussed above, in one preferred form of the present invention,articulation control assembly 285 comprises thumbstick ball assembly310, which is configured to selectively pull one or more of fourarticulation cables 220 proximally, whereby to allow selective universalarticulation of distal articulating portion 25 of shaft 15 relative toflexible proximal portion 20 of shaft 15 via movement of thumbstick ballassembly 310.

However, it has been recognized that it is also sometimes desirable toprovide a simplified articulation control assembly which may be usedwith only two articulation cables, e.g., to provide single-planearticulation of distal articulating portion 25 of shaft 15 relative toflexible proximal portion 20 of shaft 15. To that end, in one form ofthe present invention, and looking now at FIGS. 67-69 , there is shownan articulation control assembly 680 which is similar to thearticulation control assembly 285 discussed above, but which isconfigured to provide single-plane articulation, as will hereinafter bediscussed in further detail.

More particularly, articulation control assembly 680 comprises a rocker685 pivotally mounted within internal cavity 280 of handle 10. Rocker685 may be pivotally mounted within internal cavity 280 via anappropriately-formed seat disposed within internal cavity 280 of handle10 or by other means (e.g., a pivot pin). A thumb lever 690 is mountedto rocker 685 and extends proximally through a slot 695 formed in thehousing of handle 10 (FIG. 69 ). A wedge-shaped thumb rest 700 ispreferably mounted to the free end of thumb lever 690. two articulationcables 220 (not shown) are mounted to rocker 685 (e.g., by mounting theproximal ends of articulation cables 220 within diametrically-opposedslots 705 formed on rocker 685).

As a result of this construction, a user can selectively articulate, ina single plane, distal articulating portion 25 of shaft 15 byselectively moving thumb lever 690, whereby to selectively pivot rocker685 in a single plane, and thereby selectively pull one of the twoarticulation cables 220 which are mounted to rocker 685 proximally.

7.4 HHS Coil Comprising Compressive Outer Wrap

As discussed above, pull wire 230 is disposed within lumen 260 of HHScoil 225 and is able to slide freely relative to HHS coil 225 in orderto selectively actuate end effector 30 (i.e., when a user pulls trigger415 of handle 10, whereby to move pull wire 230 proximally).

It has been found that inasmuch as shaft 15 (and hence, HHS coil 225)can extend a substantial distance along a tortuous path (e.g., thoughthe colon of a patient), HHS coil 225 can sometimes longitudinallycompress (i.e., longitudinally shorten) while pull wire 230 does notlongitudinally compress (i.e., longitudinally shorten). When thisoccurs, since HHS coil 225 provides the counterforce for pull wire 230,pull wire 230 needs to be moved a further distance proximally in orderto actuate end effector 30. However, further proximal movement of pullwire 230 may not be possible if trigger 415 has reached the end of its“throw” (i.e., if trigger 415 cannot be pulled further).

In order to minimize longitudinal compression of HHS coil 225, andlooking now at FIGS. 70-72 , in one form of the present invention thereis provided a flat wound coil 710 which is wound around HHS coil 225.Flat wound coil 710 is welded to distal end 250 of HHS coil 225 and iswelded to proximal end 255 of HHS coil 225. Coil 710 rotates with HHScoil 225 and provides support to HHS coil 225, whereby to minimizelongitudinal compression of HHS coil 225. As a result of thisconstruction, HHS coil 225 does not compress longitudinally (i.e., HHScoil 225 does not shorten) when shaft 15 is disposed along a tortuouspath.

7.5 Cover for End Effector Mount 210

As discussed above, end effector 30 may be pivotally mounted within endeffector mount 210 via a pin 217A passing through the end effector andjaws 216, 217 of the grasper.

However, with certain end effectors, it is necessary to provide openingsin the sides of end effector mount 210 so that the proximal ends of theelements of the end effector have room to move when the end effector isin certain configurations. By way of example but not limitation, andlooking now at FIGS. 73 and 74 , in one form of the present invention,end effector 30 comprises scissors. More particularly, in this form ofthe invention, end effector 30 comprises a first blade 715 having adistal end 720 and a proximal end 725, and a second blade 730 having adistal end 735 and a proximal end 740. First blade 715 and second blade730 are pivotally mounted to one another and to end effector mount 210via a pin 745. When first blade 715 and second blade 730 are opened(i.e., to receive tissue, suture, etc. that is to be cut), proximal end725 of first blade 715, and proximal end 740 of second blade 730,project laterally out of end effector mount 210 (FIG. 73 ). It has beenfound that proximal ends 725, 740 can present a sharp surface which candamage surrounding equipment and/or the anatomy when end effector 30 isused in a surgical procedure, particularly when end effector 30 isrotated at a surgical site while blades 715, 730 are in their openedposition. To eliminate this issue, a cover 750 may be provided whichcovers the proximal portion of end effector mount 210. As a result, theproximal ends 725, 740 of blades 715, 730 remain covered even whenblades 715, 730 are in their open position, whereby to prevent damage tothe anatomy or other surgical equipment. In one preferred form of theinvention, cover 750 is formed out of an electrically-insulatingmaterial so that cover 750 also provides electrical insulation. This canbe advantageous where end effector 30 comprises monopolar scissors, etc.

7.6 Enhanced Handle and Trigger Ergonomics

As discussed above, in one preferred form of the present invention,trigger 415 (FIG. 25 ) is pivotally mounted to handle 10 and may beselectively pulled by a user in order to selectively actuate endeffector 30. For the purposes of illustration, trigger 415 is shown inFIG. 25 as a traditional “pistol type” trigger, and handle 10 is shownas comprising a traditional “pistol type” grip.

However, it has been found that it is sometimes desirable to provideadditional stabilization elements on handle 10 (e.g., to facilitatesingle-handed use of medical instrument 5) and/or to provide a triggerhaving a longer throw (i.e., an increased arc of movement) for providingbetter leverage.

To these ends, and looking now at FIGS. 75 and 76 , in one form of theinvention, a handle 10 comprises a “pinky” stabilizer ring 755 forreceiving the “pinky” finger of a user and a “shepard's hook”-typetrigger 760 for providing greater leverage and superior ergonomics to auser. This construction facilitates a better single-handed grip ofhandle 10 by a user and also allows a user to easily move trigger 415proximally or distally (e.g., to pull or push pull wire 230 in order toselectively close/open the jaws of a grasper, etc.)

7.7 Monopolar Electrical Current Delivery

In some circumstances it is desirable to be able to deliver monopolarelectrical power to end effector 30. By way of example but notlimitation, where end effector 30 comprises monopolar (“hot”) scissors,it is necessary to transmit electrical power from handle 10, along (orthrough) shaft 15, to end effector 30.

To that end, and looking now at FIGS. 77-80 , in one preferred form ofthe present invention, there is provided an electrical connection port(e.g., a “banana jack”) 765 disposed on the proximal end of the grip ofhandle 10 for connection to an external power supply (not shown), and awire 770 (FIG. 79 ) disposed within internal cavity 280 of handle 10 forrouting electrical power from electrical connection port 765 to a flatconductive spring 775 disposed within handle 10 (FIG. 80 ). Flatconductive spring 775 contacts the plurality of teeth 409 disposed onroticulation key 405, whereby to make electrical contact withroticulation key 405 and hence HHS coil 225 and/or pull wire 230 viaroticulation key 405. It should be appreciated that, with this form ofthe invention, ball nose spring plunger 410 is preferably omitted (i.e.,it is replaced by flat conductive spring 775). In addition, with thisform of the invention, roticulation key 405 (and teeth 409 ofroticulation key 405) are formed out of an electrically-conductivematerial (e.g., metal), as is long laser-cut hypotube 180, rotationconnector 200 and end effector mount 210. As a result, electrical powercan pass from an external power supply (not shown) to electricalconnection port 765, along wire 770 to flat conductive spring 775, fromconductive spring 775 to roticulation key 405, and then to HHS coil 225(and also to pull wire 230), along HHS coil 225 (and pull wire 230)through flexible proximal portion 20 of shaft 15, through sleeve (orcrimp) 265 to long laser-cut hypotube 180, along long laser-cut hypotube180 (and pull wire 230) through distal articulating portion 25 of shaft15, to rotation connector 200 and end effector mount 210, and from endeffector mount 210 to end effector 30. In this way, monopolar power canbe supplied to end effector 30.

7.8 Alternative End Effector

As discussed above, in a preferred form of the present invention, endeffector 30 comprises a surgical grasper having two opposed jaws 216,217 (FIG. 8 ), in another preferred form of the present invention, endeffector 30 comprises scissors 600 having opposing blades 605, 610(FIGS. 59-62 ), and in another preferred form of the present invention,end effector 30 comprises monopolar (“hot”) scissors and handle 10 ismodified to transmit electrical power from handle 10, along (or through)shaft 15, to end effector 30 (FIGS. 77-80 ).

In yet another preferred form of the present invention, and looking nowat FIGS. 81-98 , end effector 30 comprises a monopolar knife assembly800 which comprises a knife tip that can be electrified for use inmarking tissue, cutting tissue and/or cauterizing tissue. Moreparticularly, knife assembly 800 comprises a knife 805, a knife housing820 and a pull wire 230 for (i) delivering monopolar electrical power toknife 805 so as to electrify knife 805, and (ii) moving knife 805distally and proximally, whereby to extend and retract knife 805relative to knife housing 820.

Furthermore, in this embodiment, handle 10 of knife assembly 800 isconfigured to (i) transmit monopolar electrical power along pull wire230 to knife 805, and (ii) introduce fluid so that the fluid can bepassed through shaft 15 and into the tissue for cleaning the knife (orarea surrounding the knife) during use, and/or for creating a bleb(i.e., a blister) in the tissue, as will be discussed in further detailbelow.

As can be seen in FIGS. 81 and 85 , knife 805 comprises a proximal end810, a distal end 812 and a knife blade 813 extending between proximalend 810 and distal end 812. Preferably, distal end 812 of knife 805comprises a knife tip with a rounded front portion 845 and a flattenedback portion 850. Proximal end 810 of knife 805 comprises a mount 847having a tapered distal portion 848. Preferably, proximal end 810 ofknife 805 is welded to the distal end of pull wire 230 at mount 847 sothat when pull wire 230 is moved distally, knife 805 moves distally, andwhen pull wire 230 is moved proximally, knife 805 moves proximally,whereby to extend and retract knife 805 relative to knife housing 820.In a preferred form of the present invention, pull wire 230 comprises abraided cable.

Looking now at FIGS. 81, 82 and 85 , knife housing 820 comprises acylindrical proximal portion 835 and a conical distal portion 840.Cylindrical proximal portion 835 is configured to be received within thedistal end of shaft 15 and connected to distal articulation linkassembly 70 of distal articulating portion 25. Conical distal portion840 extends distally from the distal end of shaft 15. A bore 842 extendsthrough cylindrical proximal portion 835 and conical distal portion 840and opens on the distal end 833 of conical distal portion 840.Preferably, knife housing 820 is formed out of a non-conductivematerial, e.g., ceramic, which insulates electricity and isolates theelectrical current being delivered from handle 10 to knife 805.

As pull wire 230 passes from proximal end 810 of knife 805 to handle 10,pull wire 230 extends through a tube 815. Tube 815 extends from handle10 through shaft 15 and the distal end of tube 815 terminates withinbore 842 of knife housing 820, with the opening at the distal end oftube 815 aligned with bore 842 of knife housing 820. Tube 815 acts aselectrical insulation for the electrical power traveling through pullwire 230 from the handle to knife 805, as will also be discussed infurther detail below. Tube 815 and bore 842 also serve as a fluidpathway for fluid passing from a fluid inlet port in handle 10, throughtube 815, through bore 842 and out distal end 833 of knife housing 820,as will also be discussed in further detail below.

In FIGS. 81-87 , tube 815 is shown as two separate tubes (i.e., proximaltube 825 and distal tube 830), with proximal tube 825 having a largerdiameter lumen than the diameter of the lumen of distal tube 830.However, tube 815 can also be formed as a single tube which tapers fromthe proximal end to the distal end (not shown). It should be appreciatedthat forming tube 815 with a small diameter along the entire length ofthe lumen may create too much friction between pull wire 230 and thewall(s) defining tube 815, or cause fluid passing from the fluid inletport to the distal end of knife housing 820 to build up within lumen815. Therefore, whether tube 815 is formed by two separate tubes or asingle tapered tube, it is preferable that the lumen be sized to have alarge diameter along a significant portion of the lumen in order toreduce friction between pull wire 230 and the wall(s) defining tube 815and/or to enable fluid to easily flow through tube 815 as the fluidtravels from the fluid inlet port in handle 10 and out distal end 833 ofknife housing 820. Preferably, tube 815 is formed out ofpolytetrafluoroethylene (PTFE).

As stated above, pull wire 230 can be pushed distally, and pulledproximally, through tube 815 to extend and retract knife 805 relative toknife housing 820. Significantly, proximal end 810 of knife 805 andknife housing 820 are sized and shaped to (i) prevent retraction ofknife 805 into tube 815, and (ii) limit the distance knife 805 can beprojected beyond distal end 833 of knife housing 820.

More particularly, as shown in FIG. 81 , bore 842 of knife housing 820preferably comprises a stepped bore, with the distal end 843 of steppedbore 842 having a smaller diameter than the proximal end 844 of steppedbore 842. Knife 805 moves within stepped bore 842 so as to move knife805 between its fully retracted position (FIG. 83 ) and its fullyextended position (FIG. 84 ). Mount 847 at proximal end 810 of knife 805has a diameter which is greater than the diameter of tube 815, wherebyto prevent retraction of knife 805 into tube 815. Furthermore, mount 847also has a diameter which is greater than the diameter of distal end 843of stepped bore 842, whereby to prevent extension of mount 847 of knife805 beyond distal end 843 of stepped bore 842. As can be seen in FIG. 85, tapered distal portion 848 of mount 847 has a diameter that is smallerthan the diameter of distal end 843 of stepped bore 842 so that whenknife 805 is moved distally within bore 842, tapered distal portion 848moves distally within distal end 843 of stepped bore 842 until furtherdistal movement is prevented by mount 847 contacting the shoulderseparating distal end 843 of stepped bore 842 from proximal end 844 ofstepped bore 842.

Significantly, when knife 805 is in its fully retracted position (FIG.83 ), a portion of knife 805 still extends beyond distal end 833 ofknife housing 820. The distance that the portion of knife 805 projectsout of knife housing 820 when knife 805 is in its fully retractedposition is designed to be less than the distance between the innermostlayer of the intestinal wall (i.e., the mucosa layer) and the outermostlayer of the intestinal wall (i.e., the serosa layer) in order tominimize the possibility that the knife will perforate the intestinalwall when the knife passes through the mucosa layer, as will bediscussed in further detail below and as shown in FIGS. 98A-98F.

In addition to moving knife 805 distally and proximally within tube 815so as to extend and retract knife 805 relative to knife housing 820,knife 805 may also be articulated relative to handle 10. Looking now atFIGS. 85-87 , two articulation cables 220 run through articulation cablehousings 235 from handle to distal seats 135 of distal articulation linkassembly 70 (FIG. 89 ) so that articulation cables 220 can be pulledproximally to articulate distal articulating portion 25 of shaft 15 (andthereby, knife housing 820 and knife 805), in the same manner discussedabove. However, since there are only two articulation cables (and notthe four articulation cables shown in FIGS. 15 and 16 ), knife housing820 (and thus, knife 805) can only be articulated in a single planeinstead of the universal articulation provided by the three or morearticulation cables discussed above.

If desired, the plane of articulation can be modified by rotating shaft15 from handle 10, which in turn rotates (i) flexible proximal portion20, (ii) distal articulating portion 25, and (iii) knife housing 820, aswill be discussed in further detail below. Because of the manner thatknife housing 820 is connected to shaft (i.e., with a clam shellconnector), pull wire 230 and knife 805 do not rotate when shaft 15 andknife housing 820 rotate.

Since knife 805 is substantially uniform (i.e., symmetrical), there isno need to provide independent rotational movement of knife 805 and/orknife housing 820 relative to the distal end of distal articulatingportion 25 of shaft 15 (i.e., the roticulation function referred toabove). Therefore, roticulation mechanism 295 (including HHS coil 225and roticulation knob 395) may be removed from this version of theinstrument. In place of roticulation knob 395, fluid inlet port 855 isprovided for receiving fluid for flushing, as will be discussed infurther detail below.

Looking now at FIGS. 90-97 , a further embodiment of handle 10 is shown.Handle 10 has been specifically designed to provide the motion necessaryfor actuating knife 805. More particularly, in this form of theinvention, handle 10 comprises:

(i) a slider 860 for selectively actuating pull wire 230 (and henceselectively moving pull wire 230 proximally and distally so as toretract and extend, respectively, knife 805 relative to knife housing820);

(ii) a thumb stick 315 of articulation control assembly 285 forselectively moving articulation cables 220 (and hence selectivelyarticulating distal articulating portion 25 of shaft 15 and knife 805away from the shaft axis, within a single plane);

(iii) actuation lever 365 of push rod lock assembly 290 for selectivelylocking articulation control assembly 285 in a desired position (andhence locking thumb stick 315 and distal articulating portion 25 ofshaft 15 in a selected position); and

(iv) rotation knob 545 of rotatable shaft adapter mechanism 525 forallowing shaft 15 (i.e., both flexible proximal portion 20 and distalarticulating portion 25) and knife housing 820 to be selectively rotatedrelative to handle 10 in order to modify the plane of articulation. Inthis embodiment, rotation knob 545 is selectively locked to handle 10 bya finger latch 865.

As stated above, handle 10 is configured to transmit monopolarelectrical power along pull wire 230 to knife 805. To that end, andlooking at FIGS. 90-94 , in one preferred form of the present invention,there is provided an electrical connection port (e.g., a “banana jack”)870 disposed on the proximal end of the grip of handle 10 for connectionto an external power supply (not shown), and a wire 875 (FIGS. 91, 92and 94 ) disposed within internal cavity 280 of handle 10 for routingelectrical power from electrical connection port 870 to pull wire 230.Wire 875 is connected to pull wire 230 with at least one crimp. Flatconductive spring 885 acts as a detent feature and also acts as aconductor to apply voltage through pull wire 230 to knife 805, wherebyto make electrical contact from electrical connection port 870 to knife805 via pull wire 230. As a result, electrical power can pass from anexternal power supply (not shown) to electrical connection port 870,along wire 875 to pull wire 230, and along pull wire 230 to knife 805.In this way, monopolar power can be supplied to knife 805.

As also stated above, handle 10 is provided with a fluid inlet port 855so that fluid may be introduced into handle 10, passed through tube 815,out of distal end 833 of knife housing 820 and into the tissuesurrounding knife 805. More particularly, and looking now at FIGS. 95-97, the proximal end of tube 815 is bonded to fluid inlet port 855 inhandle 10, whereby fluid may be introduced into fluid inlet port 855 andflow distally through tube 815 and out of distal end 833 of knifehousing 820. Preferably, an insert 895 is provided to prevent fluid fromflowing proximally within handle 10 along the path of pull wire 230(which extends through the handle to provide the electrical path fromthe handle to the knife). Pull wire 230 extends through insert 895 andinsert 895 is sealed with an O-ring 900. The seal around pull wire 230is created when insert 895 applies pressure to (i.e., deforms) O-ring900 around pull wire 230.

At the distal end of the instrument, and as shown in further detail inFIG. 98 , mount 847 of knife 805 is formed with concave portions 905 inbetween convex portions 910 in order to permit fluid to flow throughtube 815 through bore 842, and out distal end 833 of knife housing 820.More particularly, concave portions permit fluid to be passed out of thedistal end of knife housing 820 even when knife 805 is in its fullyextended position (FIGS. 81 and 84 ) (i.e., when mount 847 of knife 805is in contact with the shoulder separating proximal end 844 of steppedbore 842 from distal end 843 of stepped bore 842). Therefore, fluid canbe passed out of the distal end of knife housing 820 regardless ofwhether knife 805 is extended or retracted from knife housing 820.

Fluid is passed out of the distal end of knife housing 820 in order toflush away debris that builds up on knife 805 or in the surroundingtissue during tissue cutting or cauterization.

Fluid can also be passed out of the distal end of knife housing 820 tocreate a bleb (i.e., a blister) in the tissue to separate thesub-mucosal layer from the muscularis mucosal layer so that the mucosaland sub-mucosal layers can be excised. More particularly, and lookingnow at FIGS. 98A-98F, to create a bleb, knife 805 is electrified andinserted through the mucosa layer while knife 805 is in its retractedposition (FIG. 98A). It is preferable to inject knife 805 through themucosa layer while the knife is in its retracted position (FIG. 83 ) sothat the knife does not penetrate too far into the intestinal wall andunintentionally perforate the intestinal wall. After knife 805 has beeninserted through the mucosa layer (FIG. 98B), fluid is injected underthe mucosa layer in order to lift the sub-mucosal layer away from theunderlying tissue (i.e., muscularis mucosae) (FIG. 98C). Knife 805 isnow extended (FIG. 98D) and power is delivered to knife 805 to cuttissue. Significantly, knife 805 can be moved laterally and pulledproximally against the wall of the mucosa so that flattened back portion850 retracts the mucosa (i.e., tensions the mucosa) while knife blade813 cuts the mucosa (FIGS. 98E and 98F). If desired, prior to creatingthe bleb, power can be delivered to knife 805 to mark a border aroundthe tissue that is to be excised.

The fluid injected through knife housing 820 is typically saline.However, if desired, methylene blue dye can be added to the saline toassist the user in viewing where the user is cutting. Furthermore, otherfluids could be injected with (or instead of) saline (e.g., gel-likefluids to increase duration of bleb formation, temperature sensitivefluids, etc.).

In an exemplary use of knife assembly 800 in a minimally-invasiveprocedure, knife 805 is retracted; shaft 15 is straightened; handle 10is longitudinally advanced so as to longitudinally advance knife 805through a portal (e.g., through a tool channel of an endoscope) and intothe body (e.g., along a tortuous path); handle 10 is longitudinallyadvanced and/or rotated, and/or distal articulating portion 25 of shaft15 is bent, so that knife 805 is adjacent to the target tissue at theinternal site; knife 805 is extended; monoelectric power is delivered toknife 805; knife 805 is used to perform the desired procedure (e.g.,mark tissue, cut tissue, etc.) at the internal site; knife 805 isretracted; and the knife 805 is withdrawn from the internal site, e.g.,handle 10 is longitudinally withdrawn through the portal (during whichthe handle may also be rotated, and/or distal articulating portion 25 ofshaft 15 is unbent as necessary), so that knife assembly 800 iswithdrawn from the body.

If desired, a syringe (or another suitable pressurized liquid source)filled with sterile water (or another fluid) may be used to inject fluidinto fluid inlet port 855 to flush water out of the distal end of knifehousing 820 to clean knife 805 (or the target area) while knife 805 isbeing used to perform the desired procedure.

Additionally, if desired, fluid may be injected into the fluid inletport 855 to flush fluid out of the distal end of knife housing 820 inorder to create a bleb (in the manner discussed above).

It will be appreciated that medical instrument 5 with knife assembly 800is capable of at least the following motions:

Motion 1—longitudinal movement of knife 805 by sliding slider 860 ofhandle 10 (sometimes referred to herein as a “longitudinal motionfunction”);

Motion 2—articulating movement of shaft 15 and knife 805 relative tohandle 10 by articulating thumb stick 315 of handle 10 to articulatedistal articulating portion 25 of shaft 15 relative to the distal end offlexible proximal portion 20 of shaft 15 (sometimes referred to hereinas a “universal articulation function”); and

Motion 3—rotational movement of shaft 15 (and hence knife housing 820)by rotational movement of rotational knob 545 of handle 10 (sometimesreferred to herein as a “torqueing motion function”).

It will also be appreciated that, if desired, the medical instrument maybe modified so as to provide less (or more) than the threeaforementioned motions, e.g., the roticulation function may be added, anadditional rotational function such as selective rotation of shaft 15may be added, additional articulation cables may be added, etc.

It will be further appreciated that medical instrument 5 with knifeassembly 800 of FIGS. 81-98 is capable of (i) transmitting monopolarelectrical power from handle 10 to knife 805; and (ii) passing fluidfrom handle 10 out of the distal end of knife housing 820.

8. Additional Constructions

In the foregoing disclosure, there is described a novel medicalinstrument 5 comprising a handle, an elongated flexible shaft andvarious end effectors disposed at the distal end of the shaft configuredfor performing a medical procedure. It should be appreciated thatmedical instrument 5 may be modified in a variety of ways in order tosupport different types of end effectors, to facilitate single-handeduse of medical instrument 5, to enhance the functionality of medicalinstrument 5, etc.

Specifically, handle 10 can be modified in a variety of ways in ordersupport different types of end effectors, to facilitate single-handeduse of medical instrument 5, to enhance the functionality of medicalinstrument 5, etc. By way of example but not limitation, the distal tipof knife 805 could be formed with a spade configuration or anotherconfiguration (instead of the rounded front/flattened back configurationshown in FIGS. 81-85, 88 and 89 ). Furthermore, slider 860 of FIGS. 90and 91 can be replaced with a trigger (e.g., trigger 415 of FIGS. 75 and76 ). Additionally, the electrical connection for delivering monopolarelectrical energy to “hot” scissors can follow the path shown in FIG. 99instead of the path shown in FIG. 79 .

9. Medical Instrument 5 with an Additional Degree of Articulation

As discussed above, in one form of the invention, novel medicalinstrument 5 generally comprises a shaft 15 having a flexible proximalportion 20, a distal articulating portion 25 configured to beselectively articulated relative to the distal end of flexible proximalportion 20, and an end effector 30 configured to be selectively rotatedrelative to the distal end of distal articulating portion 25. With thisform of the invention, longitudinal movement of handle 10 can be used toselectively move shaft 15 distally or proximally, whereby to move endeffector distally or proximally; rotational movement of handle 10 can beused to rotate shaft 15 (and hence, to also rotate end effector 30);articulation control assembly 285 (FIG. 25 ) can be used to selectivelyarticulate distal articulating portion 25 of shaft 15 relative toflexible proximal portion 20 of shaft 15, whereby to permit control overthe positioning of end effector 30; roticulation control assembly 295(FIG. 25 ) can be used to selectively rotate end effector 30 relative todistal articulating portion 25 of shaft 15; and trigger assembly 300(FIG. 25 ) can be used to selectively actuate end effector 30. It shouldbe appreciated that, in this form of the invention, flexible proximalportion 20 of shaft 15 rotates as a unit together with handle 10.

As also discussed above, in another form of the present invention, novelmedical instrument 5 may further comprise a rotatable shaft adaptermechanism 525 actuated with a rotation knob 545 (FIGS. 56-58 ) which canbe selectively rotated so as to allow shaft 15 (i.e., both flexibleproximal portion 20 and distal articulating portion 25) to beselectively rotated relative to handle 10.

Furthermore, as also discussed above, end effector 30 may comprise amonopolar knife assembly 800, wherein knife 805 can be extended andretracted relative to knife housing 820 by sliding slider 860 on handle10, wherein shaft 15 and knife 805 can be articulated relative to handle10 by articulating thumb stick 315 of handle 10 to articulate distalarticulating portion 25 of shaft 15 relative to the distal end offlexible proximal portion 20 of shaft, and wherein shaft 15 (and henceknife housing 820) can be rotated relative to handle 10 by rotatingrotational knob 545 of handle 10.

However, it should also be appreciated that, in some circumstances, itmay be desirable to add an additional degree of articulation to shaft 15of novel medical instrument 5. By way of example but not limitation,when medical instrument 5 is passed along a sharp bend in the colon (orother anatomical structure), shaft 15 of medical instrument 5 isconstrained by the anatomy and is forced to deflect along the outercurve of the bend in the colon (or other anatomical structure), therebymaking it difficult for knife 805 to cut tissue disposed along thecorresponding inner curve of the bend in the colon (or other anatomicalstructure). Thus there is a need for a medical instrument that permits agreater degree of articulation, and hence greater options for addressingthe anatomy with knife 805.

To this end, and looking now at FIGS. 100 and 101 , in another preferredform of the present invention, novel medical instrument 5 furthercomprises an intermediate articulating portion 1000 disposed between thedistal end of flexible proximal portion 20 and the proximal end ofdistal articulating portion 25. Intermediate articulating portion 1000can be articulated in a single plane (e.g., in a manner analogous to thehuman “elbow” joint) in order to provide another degree of articulationto distal articulating portion 25 of medical instrument 5, as willhereinafter be discussed in further detail. This additional degree ofarticulation is sometimes hereinafter referred to as a “grossarticulation function”.

With the additional degree of articulation provided by the grossarticulation function provided by intermediate articulating portion1000, novel medical instrument 5 is capable of at least the followingmotions:

Motion 1—longitudinal movement of knife 805 by longitudinal movement ofhandle 10 (sometimes referred to herein as a “longitudinal motionfunction”);

Motion 2—rotational movement of knife 805 by rotational movement ofhandle 10 (sometimes referred to herein as a “torquing motionfunction”);

Motion 3—articulating movement of knife 805 relative to handle 10 byarticulating distal articulating portion 25 of shaft 15 relative to thedistal end of intermediate articulating portion 1000 of shaft 15(sometimes referred to herein as a “universal articulation function”);

Motion 4—rotation of shaft 15 independently of handle 10, e.g.,selectively rotating rotation knob 545 of rotatable shaft adaptermechanism 525 to allow shaft 15 (and hence flexible proximal portion 20,intermediate articulating portion 1000 and distal articulating portion25) to be selectively rotated relative to handle 10;

Motion 5—extension and retraction of knife 805 relative to knife housing820, e.g., selectively moving slider 860 so as to move pull wire 230distally and proximally, whereby to extend and retract knife 805relative to knife housing 820; and

Motion 6—articulating movement of distal articulating portion 25 andknife 805 relative to flexible proximal portion 20 of shaft 15 byarticulating intermediate articulating portion 1000 of shaft 15 relativeto the distal end of flexible proximal portion 20 of shaft 15 (sometimesreferred to herein as a “gross articulation function”).

More particularly, and looking next at FIGS. 102-104 , in this form ofthe invention, novel medical instrument 5 comprises (i) fourarticulation cables 220 for selectively articulating distal articulatingportion 25 relative to the distal end of intermediate articulatingportion 1000, (ii) a pull wire 230 for selectively moving knife 805between its extended position and retracted position, and (iii) a grossarticulation cable 1005 for selectively articulating intermediatearticulating portion 1000 relative to the distal end of flexibleproximal portion 20, as will hereinafter be discussed in further detail.

Still looking at FIGS. 102-104 , intermediate articulating portion 1000generally comprises a flex spine 1010 (e.g., a laser-cut hypotube)having a proximal end 1015, a distal end 1020, and a central cavity 1025disposed therebetween. Proximal end 1015 of intermediate articulatingportion 1000 is mounted (e.g., welded, crimping, etc.) to distal end 40of flexible outer coil 35, and distal end 1020 of intermediatearticulating portion 1000 is mounted (e.g., welded, crimping, etc.) toproximal articulation link assembly 75.

Gross articulation cable 1005 runs from distal end 1020 of flex spine1010 to handle 10. The distal end of gross articulation cable 1005comprises a crimp (not shown), which is welded to the distal end ofgross articulation cable 1005, which is, in turn, mounted to (e.g.welded to) the inside surface of flex spine 1010 proximate distal end1020 of flex spine 810. The proximal end of gross articulation cable1005 is attached to a control assembly within handle 10, as will bediscussed in further detail below.

The portion of gross articulation cable 1005 which extends betweendistal end 1020 of flex spine 1010 and proximal end 1015 of flex spine1010 is slidably disposed within a gross articulation cable conduit 1030which is disposed within cavity 1025 of flex spine 1010. The portion ofgross articulation cable 1005 which extends from distal end 40 offlexible outer coil 35, through flexible proximal portion 20 and throughshaft 15 to handle 10 is slidably disposed within an articulation cablehousing 235. Gross articulation cable conduit 1030 is welded to proximalend 1015 of flex spine 1010, and articulation cable housing 235 iswelded to flexible outer coil 35 of shaft 15, but gross articulationcable conduit 1030 is not connected to articulation cable housing 235.

Gross articulation cable conduit 1030 and articulation cable housing 235separate gross articulation cable 1005 from articulation cables220/articulation cable housings 235, whereby to ensure smooth slidingmovement of gross articulation cable 1005 within intermediatearticulating portion 1000, flexible proximal portion 20 and shaft 15(i.e., over the distance between distal end 1020 of flex spine 1010 andhandle 10, which may be substantial in length (e.g., 95 cm-140 cm) andwhich often follows a tortuous path when medical instrument 5 isdisposed in a patient).

Gross articulation cable conduit 1030 is constructed so as to be morecompressible than articulation cable housing 235 so as to ensure thatflex spine 1010 can deflect to a desired angle. In one preferred form ofthe invention, gross articulation cable conduit 1030 comprises a coiledspring such that proximal movement of gross articulation cable 1005causes flex spine 1010 to articulate relative to distal end 40 offlexible outer coil 35 while allowing gross articulation cable conduit1030 to compress along its longitudinal dimension.

As a result of this construction, by selectively moving grossarticulation cable 1005 proximally, flex spine 1010 of intermediatearticulating portion 1000 can be selectively articulated laterallyrelative to distal end 40 of flexible outer coil 35, whereby toselectively articulate intermediate articulating portion 1000 of shaft15.

Significantly, inasmuch as only a single gross articulation cable 1005is provided, intermediate articulating portion 1000 can only bearticulated in a single plane. However, if desired, additional grossarticulation cables 1005 may be provided if articulation in additionalplanes is desired, as will be apparent to one skilled in the art in viewof the present disclosure.

Looking next at FIGS. 100, 101 and 105-108 , a preferred mechanism forselectively moving gross articulation cable 1005 is shown.

More particularly, as discussed above, handle 10 generally comprises aninternal cavity 280, an articulation control assembly 285 forselectively moving articulation cables 220 (and hence selectivelyarticulating distal articulating portion 25 of shaft 15), a push rodlock assembly 290 for selectively locking articulation control assembly285 in a desired position (and hence locking distal articulating portion25 of shaft 15 in a selected position), a slider 860 for selectivelyactuating pull wire 230 (and hence selectively moving knife 805 distallyand proximally relative to knife housing 820), and a rotatable shaftadapter mechanism 525 for selectively rotating shaft 15 (i.e., flexibleproximal portion 20, intermediate articulating portion 1000 and distalarticulating portion 25) relative to handle 10.

In this form of the present invention, handle 10 is also provided with agross articulation control assembly 1035 for selectively moving grossarticulation cable 1005 proximally or distally (and hence selectivelyarticulating flex spine 1010 of intermediate articulating portion 1000of shaft 15 relative to flexible proximal portion 20 of shaft 15).

Gross articulation control assembly 1035 generally comprises a spindlehousing 1040 fixedly mounted within internal cavity 280 of handle 10, aspindle 1045 configured to be selectively rotated within spindle housing1040, and a knob 1050 configured to be engaged by a user.

The proximal end of gross articulation cable 1005 exits the proximal endof shaft 15, passes through a portion of internal cavity 280 of handle10, and is mounted to spindle 1045 (e.g., via a crimp welded to grossarticulation cable 1005 and to spindle 1045, via welding grossarticulation cable 1005 directly to spindle 1045, etc.). Cable housing235 for gross articulation cable 805 preferably terminates at theproximal end of shaft 15, however, if desired, cable housing 235 forgross articulation cable 1005 may extend into internal cavity 280 ofhandle 10 and terminate at the outer wall of spindle housing 1040.

As a result of this construction, when knob 1050 is rotated in a firstdirection, the proximal end of gross articulation cable 1005 is pulledproximally, whereby to selectively articulate flex spine 1010 ofintermediate articulating portion 1000 of shaft 15 from a straightconfiguration to an articulated configuration (relative to flexibleproximal portion 20 of shaft 15), and when knob 1050 is rotated in asecond, opposite direction, the tension on the proximal end of grossarticulation cable 1005 is relaxed and allowed to move distally, wherebyto enable flex spine 1010 of intermediate articulating portion 1000 ofshaft 15 to return to its straight, non-articulated configuration.

It should also be appreciated that, if desired, flex spine 1010 ofintermediate articulating portion 1000 can be configured toautomatically return to its straight (i.e., non-articulated)configuration when knob 1050 is released by a user. By way of examplebut not limitation, flex spine 1010 may be formed out of a resilientflexible material that is biased towards assuming a straightconfiguration. As a result of this construction, releasing knob 1050 ofgross articulation control assembly 1035 permits gross articulationcable 1005 to move distally (i.e., under the power of the biasing forceprovided by the resilient nature of flex spine 1010), whereby to permitflex spine 1010 to return to its straight (i.e., non-articulated)configuration. Alternatively and/or additionally, if desired, anadditional gross articulation cable 1005A (not shown) may be provided,wherein the distal end of the additional gross articulation cable 1005Ais mounted (e.g., diametrically opposed to gross articulation cable1005) to the inner surface of flex spine 1010 proximate distal end 1020of flex spine 1010, whereby to help facilitate returning flex spine 1010(and hence intermediate articulating portion 1000) to its straight(i.e., non-articulated) configuration and/or articulating flex spine1010 in a second, opposite direction.

It is important to note that rotating knob 1050 of gross articulationcontrol assembly 1035 so as to articulate flex spine 1010 ofintermediate articulating portion 1000 typically requires the use of twohands (i.e., one hand to grip handle 10, and the other hand to rotateknob 1050). However, it should be appreciated that, if desired, knob1050 could be replaced with a lever (not shown) or other actuationmeans, so as to facilitate one-handed articulation of flex spine 1010 ofintermediate articulating portion 1000.

In an exemplary use of this form of novel medical instrument 5 in aminimally-invasive procedure, knife 805 is retracted; shaft 15 isstraightened; handle 10 is longitudinally advanced so as tolongitudinally advance knife 805 through a portal and into the body(e.g., along a tortuous path); handle 10 is longitudinally advancedand/or rotated, and/or distal articulating portion 25 of shaft 15 isarticulated, and/or intermediate articulating portion 1000 isarticulated so that knife 805 is adjacent to the target tissue insidethe body; knife 805 is extended; monoelectric power is delivered toknife 805; knife 805 is used to perform the desired procedure (e.g.,mark tissue, cut tissue, etc.); knife 805 is retracted; and medicalinstrument 5 is withdrawn from the body, e.g., handle 10 islongitudinally withdrawn through the portal (during which the handle mayalso be rotated, and/or distal articulating portion 25 of shaft 15 isstraightened (i.e., moved so as to assume its non-articulatedconfiguration), and/or flex spine 1010 of intermediate articulatingportion 1000 is straightened (i.e., moved so as to assume itsnon-articulated configuration).

If desired, a syringe (or another suitable pressurized liquid source)filled with sterile water (or another fluid) may be used to inject fluidinto fluid inlet port 855 to flush water out of the distal end of knifehousing 820 to clean knife 805 (or the surrounding tissue) while knife805 is being used to perform the desired procedure.

It will be appreciated by those skilled in the art that, if desired, themedical instrument may be modified so as to provide less (or more) thanthe aforementioned motions, e.g., the roticulation function may beadded, an additional rotational function such as selective rotation ofshaft 15 may be added, etc.

MODIFICATIONS OF THE PREFERRED EMBODIMENTS

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

1. Apparatus for performing a minimally-invasive procedure, the apparatus comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly comprising a knife; a handle attached to the proximal end of the shaft; wherein the shaft comprises a flexible portion and an articulating portion, wherein the flexible portion extends distally from the handle and the articulating portion extends distally from the flexible portion; wherein at least one articulation cable extends from the handle to the articulating portion, such that when tension is applied to the at least one articulation cable, the articulating portion deflects; wherein an actuation element extends through the shaft from the handle to the knife, such that when the actuation element is moved, the knife is moved; and wherein the actuation element transmits electrical power from the handle to the knife.
 2. Apparatus according to claim 1 wherein the knife comprises a distal end and a proximal end, and further wherein the distal end of knife comprises a rounded front portion and a flattened back portion.
 3. Apparatus according to claim 1 wherein the knife comprises a distal end and a proximal end, and further wherein the proximal end of the knife comprises a mount.
 4. Apparatus according to claim 3 wherein the mount comprises a distal end, a proximal end and a cylindrical wall extending between the distal end and the proximal end, and further wherein the cylindrical wall is recessed to provide a plurality of concave portions and a plurality of convex portions.
 5. Apparatus according to claim 1 wherein the knife is received in a knife housing, and further wherein the actuation element extends and retracts the knife relative to the knife housing.
 6. Apparatus according to claim 5 wherein the knife housing comprises a stepped bore having a first portion and a second portion, wherein the first portion is distal to the second portion, and further wherein the first portion has a smaller diameter than the second portion.
 7. Apparatus according to claim 6 wherein the second portion limits extension of the knife relative to the knife housing.
 8. Apparatus according to claim 1 further comprising a tube extending from the handle to the distal end of the shaft.
 9. Apparatus according to claim 8 wherein the actuation element extends through the tube.
 10. Apparatus according to claim 8 wherein the tube is configured so that fluid can be passed through the tube from the handle to the distal end of the shaft.
 11. Apparatus according to claim 10 wherein the handle comprises a fluid inlet port for receiving fluid. 12.-13. (canceled)
 14. Apparatus according to claim 12 wherein the articulating portion and the second articulating portion articulate independently of one another.
 15. A method for creating a bleb in tissue, the method comprising: providing apparatus comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly comprising a knife; a handle attached to the proximal end of the shaft; wherein the shaft and the handle are configured to so that fluid can be passed from the handle to the distal end of the shaft and into tissue; wherein an actuation element extends through the shaft from the handle to the knife, such that when the actuation element is moved, the knife is moved; and wherein the actuation element transmits electrical power from the handle to the knife; inserting the knife through tissue to be excised; and injecting fluid into the tissue to lift the tissue to be excised away from underlying tissue.
 16. A method according to claim 15 wherein the knife is retracted relative to the distal end of the shaft when the knife is inserted through tissue.
 17. A method for performing a minimally-invasive procedure, the method comprising: providing apparatus for performing a minimally-invasive procedure, the apparatus comprising: a shaft having a distal end and a proximal end; a monopolar knife assembly attached to the distal end of the shaft, the monopolar knife assembly comprising a knife; a handle attached to the proximal end of the shaft; wherein the shaft comprises a flexible portion and an articulating portion, wherein the flexible portion extends distally from the handle and the articulating portion extends distally from the flexible portion; wherein at least one articulation cable extends from the handle to the articulating portion, such that when tension is applied to the at least one articulation cable, the articulating portion deflects; wherein an actuation element extends through the shaft from the handle to the knife, such that when the actuation element is moved, the knife is moved; and wherein the actuation element transmits electrical power from the handle to the knife; and using the apparatus to perform a minimally-invasive procedure.
 18. A method according to claim 17 wherein using the apparatus comprises delivering power to the knife to cut tissue.
 19. A method according to claim 18 wherein the knife is extended relative to the distal end of the shaft while delivering electrical power to the knife.
 20. A method according to claim 19 wherein the knife comprises a distal end and a proximal end, wherein the distal end of knife comprises a rounded front portion and a flattened back portion.
 21. A method according to claim 20 wherein the knife is pulled proximally and moved laterally while cutting the tissue so that the flattened back portion of the knife tensions the tissue while the tissue is being cut. 